About the role:

The Senior Quality Analyst is in the QA Line Ops organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. The primary responsibility is to provide on-the-floor manufacturing support for the site’s Quality on the Shop Floor (QOTSF) program. Also, supporting QA Line Operations processes, including deviation investigation, CAPAs, assessment for potential issues on the floor, environmental monitoring, aseptic sampling methods, contamination control strategies, Acceptable Quality Limit (AQL) sampling of finished product, sample management, kitting of batches, and batch record documentation. You will report to the Quality operations Supervisor.

How you will contribute:

• Responsible for Quality on the Shop Floor (QOTSF) operations, implementations, and improvements.
• Identify and assess quality risk in production operations daily. QOTSF program are part of manufacturing support and compliance enforcement. Perform QOTSF review of checklists.
• Mentor manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors. Oversee aseptic manufacturing processes, including cleanroom processes, gowning procedures, and environmental monitoring.
• Perform and support of the bulk sampling processes for bulks shipped to Round Lake from other facilities.
• Oversee Standard Operating Procedures and other Quality System Documentation relevant to their responsibilities/expertise. Approve documents to procedures, forms, and specifications.
• Develop, approve, and deliver training materials relevant to their area of expertise.
• Identify, escalate, and resolve potential compliance and safety issues. Initiate deviations and CAPAs relevant to responsibilities/expertise.
• Monitor product quality through the performance of required visual and functional testing.
• Support Quality Analyst and Quality Technician responsibilities.
• Support regulatory audits.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Contribute to a team setting within the quality and potentially with other work teams to increase efficiency, solve problems, create cost savings, improve quality, and provide new product support.

What you bring to Takeda:

• Typically requires, High School Diploma or GED with 6+ years of related work experience or Associates degree or higher and 4+ years related work experience.
• Proficient in Environmental Monitoring, Microbial sampling, and Sterile sampling techniques.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Work with JDE, EBM, TW workflows, Systech, and other LMS/DMS.
• In general, your work will be a combination of sedentary work and walking around observing the conditions of the facility.
• Will work aligned shift.
• Must be able to work non-traditional work hours or work extended hours, including weekends and holidays.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• In general, your work will be a combination of sedentary work and walking around observing the conditions of the facility.
• Must be able to carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
• Must be able to stand and/or walk for an extended period between rooms and across the site.
• May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks
• Repetitive motions with hands, wrists, turning head, bending at knees and waist
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Will work around moving equipment and machinery
• Some Clean Room and cool/hot storage conditions.
• May work with and must not be allergic to cephalosporin

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1