Policy Director

Full-Time

New Voices for Reproductive Justice (NVRJ) is a social change organization dedicated to the health and well-being of Black women, femmes, girls, and folx. New Voices was founded in March 2004 and currently operates across Pennsylvania and Ohio with offices in Pittsburgh, Cleveland, and Philadelphia. The New Voices vision is to expand the Reproductive Justice movement, which is rooted in the fundamental Human Right of us all to control our bodies across the Rust Belt and Mid-Atlantic regions. As part of this expansion, we are recruiting for the positions of: POLICY DIRECTOR BRIEF DESCRIPTION: The Policy Director will oversee New Voices for Reproductive Justice's (NVRJ) policy and advocacy portfolio, aimed at achieving and sustaining the complete health and wellness of Black women, girls, and femmes through a Human Rights and Reproductive Justice framework. The Policy Director will collaborate with the leadership team to develop and inform the organization's policy position on target issues, engage stakeholders and mobilize coalition members through issue campaigns, and manage NVRJ's policy objectives on the federal, state, and local levels. SPECIFIC RESPONSIBILITIES:  Collaborates with the President & CEO and other Leadership Team members on strategic national, state, and local policy on core Reproductive Justice issues.  Serves as the primary point of contact for the organization's policy advocacy work internally and externally.  Creates and executes a comprehensive policy plan that utilizes performance metrics in alignment with the organization's mission, vision, and strategic goals.  Supervises the Policy Team and provides local field strategy, direction, and management.  Leads the policy advocacy strategies to advance the NVRJ policy agendas.  Strengthens the organization's policy advocacy infrastructure to win policy and legislative victories.  Cultivates and sustains relationships with federal, state, and local policymakers and organizes regular meetings, policy briefings, and NVRJ policy activities, and provides research, testimony, and messaging to policymakers.  Manages national and state-based policy advocacy partnerships and coalitions, policy organizing campaigns, and participates in policy convenings at the national, state, and local level.  Analyzes and synthesizes relevant policy updates at the national, local, and state levels to steer policy engagement on crucial Reproductive Justice issues.  Collaborates with all staff to advance policy advocacy that boldly intersects with our leadership development, community organizing, and culture change work in an effective, sustainable, and innovative manner.  Works directly with the New Voices Action Leadership Team to develop our 501c4 related organization.  Tracks the organization's impact with quantitative and qualitative evaluation tools and provides strategic input.  Speaks on behalf of New Voices about the organization's policy advocacy efforts.  Coordinates with the Communications Manager to contribute policy-oriented content and messaging for use in communications, marketing materials, social media, and digital platforms.  Works directly with Leadership Team Members to complete annual reports related to our policy advocacy. EDUCATION/EXPERIENCE/MINIMUM REQUIREMENTS/CERTIFICATIONS:  Bachelor's degree in a relevant or related field such as Public Policy and Public Administration or an equivalent combination of education and experience; Master's degree preferred.  7-10 years' experience in federal and/or state policy advocacy, legislative advocacy, lobbying, federal, state, and local policymaker engagement required.  Five (5) years' minimum experience managing and supervising staff.  Three (3) years' minimum experience working in any of the following areas: Social Justice, Reproductive Justice, Human Rights, Black Women's Health, Leadership Development, Community Organizing, Policy Advocacy, Culture Change, and/or Voter Engagement.  Two (2) years' minimum experience working with Black women, femmes, girls & folx.  Previous professional experience with policy advocacy for Reproductive Justice, Health, and Rights and with a 501c4 and/or Political Action Committee (PAC) is a plus.  Act 33/34 and FBI Clearances and valid driver's license with clean driving record required. OTHER SKILLS/ABILITIES:  Direct knowledge of non-profit management, operations, leadership development, program management, community outreach and engagement, policy advocacy, and volunteer/member programs.  Must possess excellent oral and written communications skills, be comfortable with public speaking when representing NVRJ and demonstrate outstanding relationship-building and interpersonal skills.  Entrepreneurial, results-driven, energetic, and able to maintain grace under fire.  Exhibits the ability to work independently and possess excellent time management skills.  Demonstrates passion, enthusiasm, motivation, commitment, integrity, humor, optimism, positivity, and the ability to inspire others to engage with New Voices.  Proficiency in Microsoft Office and experience with database programs such as EveryAction. EQUAL OPPORTUNITY: New Voices for Reproductive Justice is an equal opportunity employer. Transgender people, gender non-conforming people, people with disabilities, and veterans are encouraged to apply. COMPENSATION: Commensurate with experience and location, plus benefits package

Location: PhiladelphiaPennsylvania, United States

Communications manager

Full-Time

New Voices for Reproductive Justice (NVRJ) is a social change organization dedicated to the health and well-being of Black women, femmes, girls, and folx. New Voices was founded in March 2004 and currently operates across Pennsylvania and Ohio with offices in Pittsburgh, Cleveland, and Philadelphia. The New Voices vision is to expand the Reproductive Justice movement, which is rooted in the fundamental Human Right of us all to control our bodies across the Rust Belt and Mid-Atlantic regions. As part of this expansion, we are recruiting for the positions of: COMMUNICATIONS MANAGER BRIEF DESCRIPTION: The Communications Manager is responsible for developing and implementing a comprehensive branding, marketing, communications, and public relations strategy that will drive New Voices for Reproductive Justice's (NVRJ) growth. The Communications Manager is a strategic thinker, tactician, and has the experience and ability to expand NVRJ's visibility, digital media presence, and national, regional, and local audiences. SPECIFIC RESPONSIBILITIES:  Develops and implements strategic and comprehensive communications and marketing programs to position New Voices as the preeminent leadership development, community organizing, policy advocacy, and culture change organization locally, regionally, and nationally for Black women, femmes, girls & folx.  Serves as the principal spokesperson to media sources and the public at the Strategic Operations Director's direction.  Develops, curates, and manages the branding, website, and social media platforms of NVRJ.  Develops communications strategies based on specific budget goals and objectives defined by the Leadership Team to create and promote leadership programs, community organizing campaigns, digital organizing, policy advocacy, culture change campaigns, special events, and other activities and overseeing the production of digital and social media, online advertising, mobile apps, broadcast, print, mail, and outdoor media.  Shapes public/press statements, including those concerning NVRJ's policies and positions on Reproductive Justice news, current events, and other relevant issues.  Provides direction and oversight in the research, writing, and editing of media kits, press releases, press conferences, press interviews, speeches, and op-ed pieces.  Develops and serves as editor for NVRJ publications such as policy briefs and annual reports, approved internal communiques such as the weekly Staff newsletter and promotional materials or items, including digital graphics, posters, postcards, invitations, flyers, and event-specific signage, including planning layout, writing, and oversight of design and print production, photo/video documentation of NVRJ events.  Collaborates with the Development Director to create and implement strategic messaging to engage current donors and supporters in fundraising efforts and craft messaging for prospective donors.  Works collaboratively with all NVRJ Staff to provide ongoing communications training and skill-building workshops and provide specific support around communications requests.  Manage NVRJ public relations campaigns and initiatives to cultivate positive relationships with critical stakeholders.  Works with the Strategic Operations Director, Leadership Team, and other staff to develop and articulate the organization's mission, vision, programs. EDUCATION/ EXPERIENCE/MINIMUM REQUIREMENTS/CERTIFICATIONS:  A Bachelor's degree in a relevant field such as Communications, Marketing, Journalism, or related field of study or an equivalent combination of education is required; Master's degree preferred.  5-7 years' experience in marketing, communications, and public relations required.  Three (3) years' minimum experience working in non-profit, community-based, and/or advocacy organizations.  Two (2) years' minimum experience working with Black women, femmes, girls & folx.  Minimum three (3) years' experience working in any of the following areas: Social Justice, Reproductive Justice, Human Rights, Black Women's Health, Leadership Development, Community Organizing, Policy Advocacy, Culture Change, and/or Voter Engagement.  Act 33/34 and FBI Clearances and valid PA driver's license with clean driving record required. OTHER SKILLS/ABILITIES:  Direct knowledge of non-profit management, operations, leadership development, program management, community outreach and engagement, policy advocacy, and volunteer/member programs.  Must possess excellent oral and written communications skills, be comfortable with public speaking when representing NVRJ and demonstrate outstanding relationship-building and interpersonal skills.  Entrepreneurial, results-driven, energetic, and able to maintain grace under fire.  Exhibits the ability to work independently and possess excellent time management skills.  Demonstrates passion, enthusiasm, motivation, commitment, integrity, humor, optimism, positivity, and the ability to inspire others to engage with New Voices.  Proficiency in Microsoft Office and experience with database programs such as EveryAction. EQUAL OPPORTUNITY: New Voices for Reproductive Justice is an equal opportunity employer. Transgender people, gender non-conforming people, people with disabilities, and veterans are encouraged to apply. COMPENSATION: Commensurate with experience and location, plus benefits package

Location: PhiladelphiaPennsylvania, United States

Development Director

Full-Time

New Voices for Reproductive Justice (NVRJ) is a social change organization dedicated to the health and well-being of Black women, femmes, girls and folx. New Voices was founded in March 2004 and currently operates across Pennsylvania and Ohio with offices in Pittsburgh, Cleveland and Philadelphia. The New Voices vision is to expand the Reproductive Justice movement which is rooted in the fundamental Human Right of us all to control our bodies across the Rust Belt and Mid-Atlantic regions. As part of this expansion, we are recruiting for the positions of: DEVELOPMENT DIRECTOR BRIEF DESCRIPTION: The Development Director works closely with the President & CEO and other Staff to achieve results that are strategically aligned with the unique mission and vision of New Voices for Reproductive Justice (NVRJ). The Development Director will provide organization-wide leadership on our fundraising endeavors. The Development Director is a critical member of the Leadership Team, supports the Board of Directors Development Committee and provides guidance to Staff on relevant development activities. The Development Director is expected to create, manage and monitor the organization’s development plan which includes grants management, institutional and individual donor development, capital campaign planning, online fundraising and special events. SPECIFIC RESPONSIBILITIES:  Serves as the primary point of contact for the organization’s development work internally and externally.  Creates and executes a comprehensive development plan that utilizes performance metrics in alignment with the organization’s mission, vision and strategic goals.  Supervises the Development Team that will consist of a Development Manager and Grants Manager.  Supports the development strategies with relationship-building and cultivation of funders, donors and financial supporters to advance the organization’s development strategy.  Strengthens the organization’s development infrastructure to identify individual and values-aligned business donors who support mission and vision of NVRJ.  Collaborates with all Staff to secure adequate funding support to deliver our leadership programs, community organizing, policy advocacy and culture change work in an effective, sustainable, and innovative manner.  Tracks the organization’s impact with quantitative and qualitative evaluation tools and provides strategic input.  Speaks on behalf of New Voices about the organization’s development and fundraising efforts.  Contributes content for use in communications, marketing materials and social media and digital platforms.  Collaborates with all Staff to manage all aspects of grant reporting and communicates with Staff to submit necessary information and data and works directly with Leadership Team Members to complete annual reports. EDUCATION/ EXPERIENCE/MINIMUM REQUIREMENTS/CERTIFICATIONS:  Bachelor’s degree in a relevant field, i.e. Public Administration, Public Policy, Business Bachelor’s degree in a relevant or related field or an equivalent combination of education and experience.  5-7 years’ experience creating and implementing development plans with a history of securing unrestricted funding and direct solicitations of funding support to foundations, individual donors and values-aligned businesses in a non-profit, social justice, community-based and/or advocacy organization.  Three (3) years’ minimum experience managing and supervising staff.  Two (2) years’ minimum experience working with Black women, femmes, girls & folx.  Two (2) years’ minimum experience working in any of the following areas: Social Justice, Reproductive Justice, Human Rights, Black Women's Health, Leadership Development, Community Organizing, Policy Advocacy, Culture Change, and/or Voter Engagement.  Act 33/34 and FBI Clearances and valid driver's license with clean driving record required. OTHER SKILLS/ABILITIES:  Direct knowledge of non-profit management, operations, leadership development, program management, community outreach and engagement, policy advocacy and volunteer/member programs.  Must possesses excellent oral and written communications skills, be comfortable with public speaking when representing NVRJ and demonstrate outstanding relationship-building and interpersonal skills.  Entrepreneurial, results-driven, energetic, and able to maintain grace under fire.  Exhibits the ability to work independently and possess excellent time management skills.  Demonstrates passion, enthusiasm, motivation, commitment, integrity, humor, optimism, positivity, and the ability to inspire others to engage with New Voices.  Proficiency in Microsoft Office and experience with database programs such as EveryAction. EQUAL OPPORTUNITY: New Voices for Reproductive Justice is an equal opportunity employer. Transgender people, gender non-conforming people, people with disabilities, and veterans are encouraged to apply. COMPENSATION: Commensurate with experience and location, plus benefits package

Location: PhiladelphiaPennsylvania, United States

Sequencing Research Operations Management (21-00972)

Temporary

Client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to Client and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, and spirit of independence and love of challenge. We look for talented people to grow our business, advance our science and contribute to our unique culture. We are seeking a talented and efficient Associate Manager, Sequencing Research Operations Management to contribute and support Sequencing Research and Genomics team. The position is located in San Diego. The successful candidate will have strong organizational and project management skills with a solid understanding of Next Generation Sequencing (NGS) operations and should be able to perform any tasks assigned by Senior Manager, Sequencing Operations in an efficient and timely manner. The candidate will be expected to interact with other teams such as IT, data managers, Bioinformatics and Biology Scientists from various Thematic Research Centers (TRC's). The scope of work will involve working with internal project stakeholders as well as external NGS vendors ensuring high levels of communication. An outstanding Associate Manager should be able to maintain oversight of all project activities, identify any issues in NGS operations and ensure that these are resolved promptly. This position requires an education in biology, biochemistry, genetics or related field of life sciences research and at least 1 year of direct experience in NGS field. Experience in pharmaceutical industry is a plus. Responsibilities will include, but are not limited to, the following: • Tracking genomics collaborative research inquiries, projects, action items, deadlines and organizing all supporting information for NGS projects. • Coordinate sample transfer through data delivery for experiments performed in-house and/or via external organizations. • Review extraction, sequencing run and data quality control stats and documenting them for future reference. • Excellent time management and organizational skill with attention to details • Self-motivated, strong communication skills, both written and oral. Strong ability to work in a fast-paced environment is essential. Strong interpersonal and communication skills with a demonstrated ability for creative thinking and problem solving. Skills/Knowledge Required: Bachelor's degree in a scientific discipline with at least 2 years' work experience or master's degree with at least 1 year of work experience. Functional/Scientific/Technical Skills: • Excellent communication skills with previous success in 3rd party engagements, to deliver high quality and value in complex scientific research objectives. • Using genomics expertise to troubleshoot various scenarios that can come up during the course of an NGS experiment. • Support and troubleshoot NGS data transfers in collaboration with Bioinformation Operations Manager. • Experience in vendor management is preferred. • Working knowledge with various project management tools like JIRA and Confluence. Tasks and Responsibilities: • Primarily responsible for end to end tracking and updates of Next Gen Sequencing projects conducted in-house by SRG with its collaborators (TRC and TM teams, non-clinical pharmacology, etc.,) across all sites. This includes tracking: Incoming projects and timelines for sample preparation and sequencing. Review and document sequencing and bcl2fatsq conversion metrics Documenting meta-data essential for project to proceed for Bioinformatics processing • Assists the Sr. Manager to interact with external vendors on sending requirements, collecting quotes, setting up projects and vendor management for all project involving CRO • Using project management software for tracking project milestones and sharing summary metrics with team and project stakeholders • Support the Sr. Manager regarding meta-data standardization in collaboration with Knowledge Sciences and tracking for all NGS projects supported by SRG • Responsible for tracking contracts and their timely renewal with vendors for Lab instruments and Software services. Additional Responsibilities: • Familiarity using LIMS systems for sample, project and output management. Support of protocol development in LIMS and through automation • Work closely with data Sciences team to implement standardization of processes, meta-data collection and data organization. • Implement best practices across project teams e.g. sequencing lab, Database management, Bioinformatics and Predictive Sciences • Monitor processes and ensure that those responsible are informed of their effectiveness, advocate for and contribute to the success of change/ process improvements when warranted. • Support the development and use of performance metrics to create a culture of continuous improvement. • Ensure smooth day-to-day operation of Sequencing Operations team to facilitate teamwork, positive team dynamics and maximize team output operations.

Location: San DiegoCalifornia, United States

Mechatronics Instructional & Classroom Support Technician 2

Full-Time

Are you passionate about industrial automation and supporting student learning? Can you collaborate with faculty to ensure a welcoming and supportive environment with students of diverse multicultural, socioeconomic and academic backgrounds? If these questions resonate with you, then we invite you to consider joining our Mechatronics Technology team as an Instructional & Classroom Support Technician 2. Clark College is currently accepting applications for a classified Instructional & Classroom Support Technician 2. This is a full-time cyclic position, working 40 hours per week while classes are in session (summer, fall, winter and spring) with time off over the quarter breaks. Classes may run Monday – Saturday. Renewal of this position is contingent upon reallocation of state support. Instructional & Classroom Support Technicians provide various instructional, classroom, and laboratory support including academic and vocational instructional programs and extension of educational activities. Duties typically include assisting in the individual or group instruction of students in development of learning skills; and working with the faculty or instructors in preparing instructional lessons, teaching aids, materials and equipment associated with shop, or laboratory instruction which requires positions to have technical knowledge of the disciplines(s). This position is expected to support the institutional mission and goals, foremost being diversity, equity and inclusion, and student success and retention. At Clark, we value equity, diversity and inclusion. We have not always gotten it right, but are committed to growing, learning, and supporting our employees. Our Office of Diversity, Equity, and Inclusion (ODEI) supports individuals with their academic, personal, and professional development, as well as provides training and educational resources for all members of the college community around diversity, inclusion, power, privilege, inequity, social equity, and social justice. The college offers further professional development for our employees through opportunities such as Employee Resource Groups, Social Justice Leadership Institute, Cross Institution Faculty of Color Mentorship program, Administrators of Color Leadership Program, and Faculty and Staff of Color Conference.” Clark College values diversity and is an Equal Opportunity Employer and Educator. Protected group members are strongly encouraged to apply. Clark College provides equal opportunity in education and employment and does not discriminate on the basis of race, color, national origin, age, disability, genetic information, sex, sexual orientation, marital status, creed, religion, honorably discharged veteran or military status, citizenship, immigration status or use of a trained guide dog or service animal. Prohibited sex discrimination includes sexual harassment (unwelcome sexual conduct of various types). The college considers equal opportunity, affirmative action, and non-discrimination to be fundamental to the mission, vision and values of the college. All faculty and staff hired at Clark College are encouraged to embrace, continually support and enhance social equity on our campus and in our community. The college provides reasonable accommodations for qualified students, employees, and applicants with disabilities in accordance with the Americans with Disabilities Act and Federal Rehabilitation Act. The following person has been designated to handle inquiries regarding non-discrimination policies, Title II and Title IX, and Affirmative Action: Darcy Rourk, Interim Vice President of Human Resources, 360-992-2119, drourk@clark.edu, 1933 Fort Vancouver Way, Baird 012, Vancouver, Washington 98663. Clark College is a smoke-free/drug free environment. This recruitment announcement does not reflect the entire job description and can be changed and or modified without notice. Job Duties and Responsibilities:

• Prepares materials for the use in the classroom or lab. Set up assignments, equipment or provide demonstrations for classes; communicates with instructor on the status of assigned tasks.
• Helps with vocational training activities and helps maintain a safe and clean learning environment.
• Ability to perform basic repairs and maintenance of mechanical, fluid power, and electronic test equipment.
• Monitors laboratories to ensure compliance with safety policy; assists in the development of safe laboratory procedures.
• Estimates quantity and quality of supplies and materials needed; orders equipment and supplies for the course; follows through with purchasing department or procurement of supplies; maintains adequate stock levels.
• Ability to work well with people of all ages from academically, culturally, and socioeconomically diverse backgrounds.
• Ability to demonstrate to others mechanical assembly, soldering, and troubleshooting techniques.
• Must be able follow supervisor’s instructions, verbally and/or by written instructions.
• Must be able to work from drawing with an understanding of mechanical, fluid power, electrical, and electronics symbols.
• Must demonstrate basic usage and proper techniques of common hand tools, such as hammers, wrenches, alignment tools and clamping devices.
• Understanding of mechanical, fluid power, electrical power, and electronic troubleshooting and failure analysis.
• Perform other related duties as required.

• One (1) year of education in Mechatronics and/or experience in the automation industry.
• Experience in operating shop equipment such as but not limited to: digital multi-meter, oscilloscope, function generator, tachometer, and automated lab equipment.
• Experience operating automated industrial equipment.

•  Ability to lift 50lbs using proper lifting technique.
•  Ability to identify mechanical, fluid power, electrical, and electronics components.
•  Ability to identify various types of materials and their applications.
• The initial appointment will include a 6-month probationary period and the employee will earn permanent status after successfully completing probation.
• This position is represented by Washington Public Employees Association.
• Prior to a new hire, a background check including criminal record history will be conducted. Information from the background check will not necessarily preclude employment but will be considered in determining the applicant’s suitability and competence to perform in the position.

• Clark College online application
• Current resume, with attached references
• Cover letter describing background and experience related to qualifications and responsibilities of the position
• Responses to the supplemental questions included in the online application process:
  • Please describe your automation experience and list specific equipment used.
  • Please describe a recent experience where you led an industrial training exercise related to Mechatronics.
  • Please describe how you have implemented practices and/or participated in initiatives that promote racial and cultural equity.

Location: VancouverWashington, United States

Designer, Brand Marketing

Full-Time

About the Role: RealSelf is looking for a Designer, Brand Marketing on the Consumer Marketing team to play a pivotal role in creating a world-class creative experience, helping to lead our effort in evolving into a most-loved and highly recognized brand. The Designer, Brand Marketing, will be responsible for ideating, creating, and executing innovative and immersive creative marketing, content, and consumer campaigns across all channels for the RealSelf brand. Projects range includes brand design, film/video, motion, landing pages, emails, and digital campaign objects such as social. Responsibilities include identifying key concepts and themes, ideating around the consumer experience, developing and pitching concepts, execution, and delivery, leading and inspiring a high-performance team. A successful candidate must be comfortable creating at the strategic level (understanding high-level briefs and applicable technologies) while delivering at the tactical level (developing/delivering concepts and experiences ahead of trends, on-brand, and actionable). This candidate will have an elevated aesthetic image and design sense paired with experience collaborating with content & copy teams on applicable language. The Designer, Brand Marketing, who joins the team must be passionate about the beauty and aesthetics category, have a high energy level and be ready to jump into a fast-paced, dynamic environment.  In this role, you will: 

• Be a lead creative practitioner, the bridge between creative strategy and marketing-led consumer-centered experience for our campaign and content calendar priorities, aligning with and building on our brand standards
• Own, deliver, and manage projects and creative workflows across multiple cross-functional teams to create beautiful and engaging solutions within deadline parameters.
• Be resourceful and clever, with proven experience working at the forefront of creativity, intelligence, and efficiency.
• Solve challenges quickly and delightfully, keeping the consumer at the center of the work while mentoring others to emulate this behavior
• Deliver on larger marketing creative strategies and priorities
• Create and maintain innovative project plans, be a hands-on team player, and self manage as well as manage others (develop and adhere to project schedules; collaborate effectively across teams)

• 5+ years of experience in marketing-led creative art direction and design. 
• Bachelor’s degree in Communications/Graphic Design or equivalent experience
• Portfolio demonstrating innovative and immersive end to end creative experiences through the lens of the consumer
• Experience at the strategic level, partnering and collaborating on cross-functional teams, leading others as well as through creative influence
• Ability to accurately interpret and build on marketing briefs, data, and feedback loops
• Demonstrated ability to present and sell concepts with excellent verbal, visual, and written communication skills
• Close attention to detail with a keen sense of elevated design and taste, specific to image and typography
• Ability to direct and manage copy and other written expressions on behalf of the brand
• Experience art directing production efforts, including photoshoots and audio recordings
• Figma expert, expertise with Adobe Creative Cloud programs (Illustrator, Indesign, Photoshop) and Google tools 
• Experience with video and motion design 
• Portfolio demonstrating relevant experience required with application 

This role is open to fully remote candidates in most states.  Working remotely from a primary residence outside the United States is currently not permitted.  

Location: United States

QA Manufacturing Associate (21-01126)

Temporary

Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. 1. Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs. 2. Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. 3. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. 4. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. 5. Reviews, approves and provides guidance for quality master data 6. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs. 7. Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data. 8. Assist Operations by providing quality oversight and guidance for atypical events. 9. May provide guidance to less experienced staff. 10. May support the Quality approval of Master Batch Records. 11. Supports the Quality review and closure manufacturing deviations. 12. May support release of incoming or manufactured products. 13. Other duties as assigned. • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. • A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on product quality preferred • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. • Knowledge of US and EU cGMP regulations and guidance. • Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable. Additional Job Requirements: None

Location: DevensMassachusetts, United States