Biogen · 1 day ago
Associate III, Quality Assurance (On The Floor, Swing Shift)
Research Triangle Park, NC
Full-time
Onsite
Entry, Mid Level
$69K/yr - $90K/yr
2+ years expBiogen is a mid-sized biotechnology company committed to delivering life-changing medicines. The QA Associate III will ensure compliance with quality standards and assist in maintaining cGMP compliance while performing various quality assurance activities.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
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
Qualification
Required
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
Previous relevant industry experience in a GMP manufacturing environment
Experience with column packing or reviewing column pack binders
Benefits
Medical, Dental, Vision, & Life insurances
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
Company data provided by crunchbase