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North Carolina, United States
Onsite
This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule
About This Role
The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate III identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Associate III performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The QA Associate III should be able to work effectively, independently and within a team framework, across multiple business areas and levels of the organization.
What You’ll Do
Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. This includes but is not limited to Review and Approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, Validity Rules (FRRV/BOM), existing/revised MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; on the Manufacturing floor record review and observations, performing WORCs, performing inspection readiness walkthroughs, and oversight of Manufacturing operations.
Supports resolution of both technical and compliance issues/gaps of low complexity
CAPAs can be assigned and closed based on their understanding of the CAPA intent and review/approval of the associated document (i.e.PRCD ) at Management discretion/oversight.
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. Provides training within and across functions, as applicable
Approximately 50% of time in this position will be spent on the manufacturing floor
Other duties as assigned
Required Skills
Bachelor’s Degree required in life sciences or related
Minimum of 2 years of experience working in a quality assurance position within a GMP pharma or biotech manufacturing environment
Ability to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
Excellent written, verbal, and interpersonal communication skills
Familiarity with downstream process manufacturing
Preferred Skills
Previous relevant industry experience in a GMP manufacturing environment
Experience with column packing or reviewing column pack binders
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
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 Biogen.
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.
