Biogen · 5 hours ago
Sr. Associate I, Quality Assurance (On The Floor Parenteral Filling, Nights)
Triangle, NC
Full-time
Onsite
Mid, Senior Level
$79K/yr - $103K/yr
4+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Senior Quality Associate I role involves quality oversight within the Quality Assurance team, focusing on ensuring compliance in cGMP production activities and supporting various quality management functions.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Ensures Product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution
Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions
Actively monitors the applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency
Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required
Assists QA 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
Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions
Other job duties as assigned
Qualification
Required
Bachelor's degree preferably in a field of science or biotechnology, or related
Minimum of 4 years of experience working in a quality assurance capacity in a biotech or pharmaceutical manufacturing environment
Experience working in a parenteral filling OR aseptic environment OR experience working with isolators
Experience working on the floor and reviewing and approving batch records
General understanding of relevant FDA/EMA regulations and compliance
Strong organizational skills and detail oriented aptitude
Ability to develop innovative/creative solutions to issues of moderate complexity
Excellent oral and written communication skills
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 (82)
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
thecanadianpressnews.ca
2025-12-24
2025-12-24
Company data provided by crunchbase