Associate III, Quality Assurance (On The Floor, Swing Shift)

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