- Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
- Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
- Provides assistance to site personnel performing deviation investigations, CAPAs, and change controls.
- Focused primarily on providing support and guidance on non-complex and routine quality-related issues.
- Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
- Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
- Administrates QA Operations systems in support of GMP manufacturing activities; material hold, equipment out of service, etc.
- Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.
- Supports deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
- Revises and reviews department-specific controlled documents independently.
- Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.
- Identifies and proposes Quality Process and system improvements.
- Complete mandatory training within required timeframe.
- Performs additional duties, as assigned, including support of QA Compliance Review, Quality Compliance, and Supplier Quality functions.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years experience in Regulated (food, medical device, or pharma/biotech) industry.
- Understands and applies good working knowledge of quality and GMP principles.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
- Must be able to read, write and converse in English.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
- Wrist and hand motion (e.g. typing, writing)
- Must be able to work in controlled or clean room environments requiring special gowning.
- May be required to 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.
- May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 5% travel.
Brooklyn Park, MN