Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Assurance Specialist II in our Brooklyn Park office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Quality Assurance Specialist II working on the team, you will be empowered to help increase quality and service to both internal and external clients. In this role, you will contribute to Takedaâs mission by helping to build a better tomorrow for our patients and their families. A typical day will include:
SHIFT: Friday - Monday, Days
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 drugÂ 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.
Analyzes and interprets projects, studies, or investigations to determine next steps in consultation with management. Makes basic decisions independently. Reviews more complex decisions with management.
Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.
Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
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 Compliance and Supplier Quality functions.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 yearsâ experience in Regulated (food, medical device, or pharma/biotech) industry.Â
Understands and applies good working knowledge of quality and GMP principles.
Familiarity or experience with the following is preferred: Auditing; basic statistics; 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
Ability to handle multiple tasks concurrently and in a timely fashion.Â
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 be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
Certified Quality Auditor (CQA) a plus
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.Â 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
Internal Number: R0023928
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.