Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Assurance Specialist II in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QA Specialist II working on the Quality team, you will be empowered to perform document review and work closely with Manufacturing to support GMP compliance.
- This individual will perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture at the Brooklyn Park site of Takeda.
- This person is responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
- This person provides assistance to site personnel performing deviation investigations, CAPAs and change controls.
This position is 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.
- Analyzes and interprets projects, studies, or investigations to determine next steps in consultation with Supervisor. Makes basic decisions independently. Reviews more complex decisions with management.
- Identifies and resolves basic technical issues using problem-solving skills, in consultation with Supervisor.
- Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
- Revises department-specific controlled documents, independently.
- Receives minimal supervision on routine work assignments. Receives specific instruction on new work.
- Participates in required training and keeps training files current.
- Identifies and proposes Quality Process and system improvements.
- Performs additional duties, as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE 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.
- Wrist and hand motion (e.g. typing, writing)
- Must be able to work in controlled or clean room environments requiring special gowning
- Willingness to travel to various meetings or client sites, including overnight trips
- Requires approximately 0-5% travel
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.