- Perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
- Responsible for review of documentation in support of commercial drug substance manufacturing.
- Provides guidance to site personnel performing deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis.
- Focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues.
- Performs documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
- Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
- Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
- Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
- Reviews deviations, investigations, and CAPAs associated with cGMP compliance. Supports change controls related to Quality topics.
- Writes new documents and revises existing documents, independently.
- Performs QA review/approval of controlled documents.
- Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
- Develops and provides training on department-specific procedures and systems. Trains and mentors peers.
- Identifies and proposes Quality Process and system improvements.
- Participates in internal or supplier audits as needed.
- Complete mandatory training within required timeframe.
- Performs additional duties, as assigned, including support of QA Operations, Quality Compliance, and Supplier Quality functions.
Education, Behavioral Competencies and Skills:
- BA/BS (or Master's) in any Life Science discipline preferred, and/or 5+ years experience in Regulated (food, medical device, or pharma/biotech) industry.
- Must have direct experience with Quality Assurance within the Life Science industry.
- Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
- 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.
- Familiarity or experience with the following is preferred: Auditing; basic statistics; Certified Quality Auditor (CQA); Internal / External Auditing; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations
Brooklyn Park, MN