Associate III, Quality Assurance
BiogenAbout the role
About This Role
This is a full time, on-site position with M-F business hours
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, oversight of Manufacturing operations; QA representative (support the QA Lead) for NPI Tech Transfers and Restart Programs
Serve as a technical consultant for quality related issues and assuring compliance with regulatory requirements and site procedures. Supports resolution of both technical and compliance issues/gaps of low to moderate complexity
Execute activities including technical writing, investigation support (root cause analysis/impact assessment). This includes that CAPAs may be closed based on their understanding of the CAPA intent and review/approval of the associated document (i.e. PRCD) at Management discretion/oversight; may write and/or review/approve Minor investigations/deviations based on demonstration of competencies at Management discretion/oversight; and may review and provide GCC assessments based on demonstration of competencies at Management discretion/oversight
Assist 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. Supports and/or assists in GxP quality systems-related training. Provides training within and across functions, as applicable
Other duties as assigned
Required Skills
Bachelor’s Degree required, preferred in life science
Minimum 2 years of relevant Quality experience within a pharmaceutical or biotech GMP manufacturing environment
Understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
Must be able 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 required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes and decisions
Preferred Skills
Experience with batch related documentation
Experience with quality management systems
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 o
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s