Job Description
This position has a working schedule of 12PM/Noon to 12AM/midnight on a 2-2-3 rotation
The Associate III, Quality Assurance Biologics will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities include review of batch record pages, logbooks, equipment reports, and directly collaborating with Manufacturing Associates to assist with problem resolution. Additionally, activities include, but not limited to, the following: Data and Documentation Review and Analysis, Batch Record Review, and Deviations. The QA Associate II will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.
What You'll Do
- Provide quality oversight during batch manufacturing
- Responsible for compliance monitoring of the manufacturing area
- Assures compliance against applicable procedures providing QA controlled document creation, revision, retirement, and issuance requirements
- Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition
- Executes activities including intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity)
- Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
- Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen
Who You Are
The ideal candidate is curios, eager to learn, asks copious questions and accepts nothing at face value without evidence. Additionally, the candidate has excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.
Qualifications
- Bachelor's Degree required, preferred in a science field or related
- Minimum 2 years of quality assurance experience in a GMP/cGMP environment
- General understanding of relevant FDA/EMA regulations
- Plans schedules and arranges own activities when accomplishing objectives
- Must be able to deal with ambiguity
- General understanding of Quality concepts; able to practice and implement them
- Ability to develop innovative/creative solutions to issues of moderate complexity
- Detail oriented aptitude
- General understanding of the cell culture process
- Excellent oral and written communication skills
Preferred qualifications
- Experience in QA On the floor/shop floor, including experience with batch record review
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.