Sr Associate II, Quality Control Raw Materials
About The Position
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.
Requirements
- 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
Nice To Haves
- Advanced working knowledge of operations/quality systems utilized in QC operations/support teams
- Advanced technical writing skills
- Experience working with aseptic technique
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
