The Quality Systems Specialist I is primarily responsible for implementing, maintaining and improving quality systems processes and programs to include: Supplier Quality, Audit, Investigation Systems, Periodic Product Review, Product Complaint, Regulatory Inspections, Document Control, Change Management, Training, and Technical Document review. This position may support one or many of the Quality Systems and Compliance functions.

Responsibilities:

Support and maintain the following Quality System areas to assure compliance to applicable regulatory requirements:

Supplier Quality Management System

• Manage suppliers of materials, parts, and services through a risk- based approach.
• Maintain the supplier evaluation process to ensure adequate quality oversight and compliance of vendors and service suppliers by managing or conducting supplier questionnaires, performing external audits, and/ or establishing quality agreements.

Internal and External Audit Programs

• Support internal and external audits

Investigation Systems and Planned Deviation System

• Support systems cross functionally
• Support investigation teams on root cause analysis techniques and processes
• Support implantation, monitoring, and determining effectiveness of actions
• Facilitate meetings, provide systems visibility, communicate status, and facilitate closure of aging items.

Periodic Product Review

• Author annual product reviews for marketed products

Product Complaint

• Manage product complaint system, perform investigation, and handle returned product.

Management Review

• Track, trend and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.

Miscellaneous

• Provide Quality System and Compliance oversight for internal and external customers, by working cross functionally, to ensure Quality System processes, compliance requirements, and improvement programs are implemented to meet drug/biologic cGMPs based on products regulatory phase.
• Review and approve cGMP documents and/ or regulatory submission documents for compliance to internal procedures and applicable regulations.
• Support the design, implementation, and maintenance of a robust and compliant framework of cGMP policies, procedures and processes.
• Provides support and guidance to the teams responsible for establishing Quality Management System elements in their functional area of responsibility to build a strong quality driven culture by collaborating with Manufacturing and Technical Operations, Materials Management, Quality Control, R&D and Regulatory.
• Acts as a Quality team member to facilitate QMS implementation and continuous improvement activities.

Support Training Program

• Mentor colleagues on training process, serve as SME on system and requirements.
• Establish visibility to overdue training, communicate status, and drive completion. May include the implementation and validation of software to facilitate administration.
• Perform new hire and annual GMP/GDP training in conjunction with Quality Systems and Compliance Manager.
• Prepare and provide support for agency audits of Rebiotix (FDA or other.)
• Supports front room and back room activities for regulatory inspections.
• Supports the activities related to BLA submission, IND and other regulatory filings as applicable.
• Provides review of CMC section(s) to ensure alignment with current procedures and/or supporting data/justification.
• Performs cross functional alignment with Regulatory to meet FDA requests for information and Annual Review requirements
• Support other Quality functions
• Support processes related to document control, change management, training, periodic review system/process, and record retention.
• Support the integration of Electronic Quality Management Systems (EQMS).
• Any other duties as assigned for business reasons.

Education and Professional Qualifications:

• Bachelor’s degree in scientific field, preferably Microbiology

Experience:

• Two (2) or more years in the pharmaceutical and/or biopharmaceutical industry in a Quality Assurance role, preferably Quality Systems.
• Experience in 21 CFR 210, 211, 600, 610 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application.

Skills:

• Good understanding of manufacturing processes and Quality Management System concepts.
• Good oral, written, and interpersonal skills, ability to function effectively in a team and manage time efficiently, customer focused approach to activities and interactions.
• Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.
• Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs, recognize variances from cGMPs, completes routine tasks with little or no oversight and requires moderate direction to complete more complex tasks.

Working Conditions:

• Sit or stand for 8-10 hours per day.
• May require extended time on telephone
• Significant work pace and pressure due to deadlines and rapid change.
• In general, work is a mix of office and manufacturing setting.
• Able to life 25 pounds

All your information will be kept confidential according to EEO guidelines