Sr. Associate I, Quality Assurance

This is a full time, on site position with M-F business hours

About This Role

A Sr. Associate I, Quality Assurance is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities: (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation:

What You'll Do

• Batch Record Review/Product Disposition: Review documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
• Exceptions, Complaints and CAPA: Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of the investigations and provide feedback to the department owner. Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect. Collaborates with associated departments to determine the appropriate
• QA Controlled Documentation: Review and approve content for controlled documents within the quality system to ensure compliance with procedural requirements and standards. Additionally, technical reports issued requiring a Quality review are in scope of this role.

Who You Are

You are task-driven and focused; willing to proactively action to resolve, remediate and/or improve. You are collaborative and capable of being both agile and customer-focused.

Required Skills

• Bachelor's degree required, preferred in a science discipline
• Minimum 4 years of experience working in a GMP quality environment within biotech/pharmaceutical industry
• Experience in drug product batch record review and disposition
• Experience with deviations varying in complexity
• Strong knowledge in FDA/EMA regulations and compliance
• Strong organizational skills; ability to multi-task
• Investigative mindset and solid decision making skills
• Critical thinking skills and has a questioning attitude

Preferred Skills

• Experience in aseptic fill/finish manufacturing operation
• Microbiology experience
• Experience working in a parenteral filling environment
• Experience in Oral Solid Dose or Oligonucleotide manufacturing environment
• Experience supporting audits and/or investigations

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-REQ21373

Employment Type: FULL_TIME

Posted: 2025-08-07T04:06:59