Sr Associate I, Quality Control Investigator
Yesterday• Research Triangle Park, NC
About This Role
The Sr Associate I will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, Actions, and environmental excursions. The Sr Associate I must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations.
What You'll Do
- Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions
- Author technically sound moderately complex reports with minimal guidance
- Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables
- Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion
- May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports
- Participates in process improvements, supports management and QC teams
- Other duties as assigned
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Who You Are
You are passionate about solving technical, compliance gaps and areas for improvement or remediation related to quality or process. You are confident in making decisions that have potential compliance impact to methods, results, products, and/or quality systems. You work effectively, independently and within a team framework across business and multiple levels.
Required Skills
- Bachelor's degree, preferably in a field of science or biotechnology
- A minimum of 4 years' relevant experience in quality oversight of a biotechnology or pharmaceutical manufacturing operation
- Thorough understanding of and experience conducting investigations in a biotech or pharma GMP environment (preferred in quality control)
- Good working knowledge of operations/quality systems understands work processes of QC operations/support teams (e.g., strong test method/scientific base)
- Excellent technical writing skills; authors technically sound, simple to moderately complex reports and complex reports with limited guidance
Preferred Skills
- Proficient in Trackwise, LabWare, LIMs, Kneat, and Veeva
Job Level: Professional
Additional Information
The base compensation range for this role is: $79,000.00-$103,000.00
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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Client-provided location(s): Research Triangle Park, NC
Job ID: Biogen-REQ21815
Employment Type: FULL_TIME
Posted: 2025-11-07T19:08:03
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)