Sr Associate II, Quality Control Raw Materials
Biogen
Sr Associate II, Quality Control Raw Materials
This is a Mon-Fri day shift position, fully on site
About This Role
The QC Sr. Associate II will have oversight of all activities associated with testing of raw materials and process aids, manage projects, write protocols and reports, maintain robust and compliant cGMP documentation practices. The Associate will have a fundamental understanding of the Biogen Quality Systems and be able to apply it in their daily support functions. The incumbent will be responsible for adherence to all GMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. This individual should be able to work effectively within the group as well as independently to meet assigned timelines. This role requires strong technical expertise, excellent communication, and the ability to work independently, collaboratively within a team, and across business functions.
What You'll Do
Perform scheduling of testing for raw materials and process aids
Ensure timely completion of activities and track individual assignments
Execute testing to support release and/or investigation, where applicable
Coordinate CLO submission forms and sample shipments
Support exceptions/investigations for the area
Support closure of Invalid Assays for the lab
Support cross-training program
Who You Are
You have a good understanding of the operating principles for quality control testing. The ideal candidate is naturally curious, eager to learn, asks thoughtful questions, and does not accept claims without supporting evidence. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.
Required Skills
Bachelor's Degree (Life Sciences preferred) with 5+ years of experience working in a QC GMP environment
Quality Control testing experience to include compendial tests (pH, osmo, endotoxin, total organic carbon, conductivity, etc), chemistry, or microbiology related test methods
Direct root cause analysis experience with deviations, laboratory exceptions, etc, including technical writing
Understanding of scientific principle, ability to communicate with peers and management
Effective organizational skills
Ability to coordinate multiple activities in parallel to meet required timelines
Ability to work independently and as part of a team
Demonstrated problem solving skills
Preferred Skills
Advanced working knowledge of operations/quality systems utilized in QC operations/support teams
Advanced technical writing skills
Experience working with aseptic technique
Additional Information
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.