Associate III, Quality Assurance; Floor, Swing Shift

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

Join to apply for the Associate III, Quality Assurance (On The Floor, Swing Shift) role at Biogen.

This is a full time, on-site position with a schedule of 12:00 PM to 12:00 AM on a rotating 2‑2‑3 schedule.

The QA Associate III has a working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems and have working knowledge of GxP regulations, adhering to all regulatory licenses, regulations and internal SOPs.

The QA Associate III identifies and resolves issues through collaboration with others, partnering with colleagues to resolve potential compliance concerns. They perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures and work effectively both independently and within a team framework across multiple business areas and levels of the organization.

• 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.
• Support 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.
• Approximately 50% of time in this position will be spent on the manufacturing floor.
• Other duties as assigned.

• Bachelor’s degree in life sciences or related field.
• 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.

• Previous relevant industry experience in a GMP manufacturing environment.
• Experience with column packing or reviewing column pack binders.

Professional

The base compensation range for this role is: $69,000.00–$90,000.00. 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.

• Medical, dental, vision, and life insurance
• Fitness & wellness programs including a fitness reimbursement
• Short‑ and long‑term disability insurance
• A minimum of 15 days of paid vacation and an additional end‑of‑year shutdown time‑off (Dec 26‑Dec 31)
• Up to 12 company paid holidays + 3 paid days off for personal significance
• 80 hours of sick time per calendar year
• Paid maternity and parental leave benefit
• 401(k) program participation with company‑matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

We are a global team with a commitment to excellence and a pioneering spirit. As a mid‑size biotechnology company, we provide the stability and resources of a well‑established business while fostering an…