Senior Associate I, Quality Assurance (On The Floor, Swing Shift)

About This Role

The QA Sr Associate I 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 Sr Associate I has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The Associate identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Sr Associate I performs all duties in a manner consistent with site and corporate policies cGMP safety environmental and human resources policies and procedures. The Associate should be able to work effectively independently and within a team framework across multiple business areas and levels of the organization.

WhatYoullDo

• 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/revisedMPRs 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 ( ) 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

• May work on independent projects or be involved in ongoing training for junior team members

• Other duties as assigned

Required Skills

• Bachelors Degree required in life sciences or related (or Associates Degree plus 6 years of experience)

• Minimum of 4 years of experience working in a GMP pharma or biotech manufacturing environment

• Must have experience working in QA on the floor/shop floor

• 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 experiencein a GMP manufacturing environment

• Experience with column packing or reviewing column pack binders