Sr Associate II, Quality Assurance Operations
BiogenHighlight
Summary
About the Role
About You
- Bachelor’s Degree, preferred in life science, or Associate's Degree plus 7+ years of related experience.
- Minimum 5 years of relevant quality assurance experience within a GMP pharmaceutical or biotech manufacturing environment.
- Experience reviewing and approving batch records, master records, SOPs and technical documents.
- Experience conducting and explaining investigations to quality management and regulatory bodies.
- Experience working on the floor within manufacturing environment, either as QA oversight or manufacturing operator.
- Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations.
- Excellent written, verbal, and interpersonal communication skills.
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule).
- Experience supporting product disposition.
- Experience conducting and explaining investigations to quality management and regulatory bodies is strongly preferred.
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
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Facebook, X, and YouTube.