Sr. Associate I, Quality Assurance
Job Description
This is a full time, on site position with M-F business hours
About This Role
Sr. Associate I 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. It is expected that this role will report directly into a Sr. Manager.
What You’ll Do
- Product Disposition: Reviews 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: Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of the investigations and provides 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
Looking for someone who is task driven and focused; taking action to resolve, remediate and/or improve. Collaborative person capable of being both agile and customer focused.
Qualifications
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 supporting audits and/or investigations
Additional Information
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.
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Are you ready to take your career to the next level? Join Biogen as a Senior Associate I in Quality Assurance at our Research Triangle Park facility! This full-time, on-site position offers the unique chance to play a key role in the quality oversight of crucial manufacturing processes within our Drug Product Parenteral facility. In this role, you'll dive deep into batch records, manage exceptions and investigations, and ensure our QA controlled documentation meets the highest standards of excellence. Your meticulous attention to detail will shine as you review production records and test methods, ultimately ensuring compliance and product acceptability for GMP production activities. Collaborating with various teams, you’ll assess critical investigations and contribute significantly to complaint resolutions, utilizing your strong analytical skills. A Bachelor’s degree in a science discipline and a minimum of 4 years’ experience in a GMP quality environment in the biotech or pharmaceutical industry are required, along with familiarity in FDA and EMA regulations. If you’re a proactive problem-solver with an investigative mindset, we want to hear from you! At Biogen, we celebrate diversity and are committed to an inclusive environment where every employee thrives. Join us in our mission to deliver life-changing medicines and make a positive impact on patients' lives every day!
By
Biogen
Drive innovation to defeat the most complex and devastating diseases.
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