Associate I, Quality Control/Sample Control
- Research Triangle Park, NC
- Department: Quality
- Region: US
About This Role
Execute the routine processing of samples required for testing by Quality Control Laboratories. Support sample handling activities related to preparation of test samples, use of LIMS applications and communication with various departments in response to requests or inquiries for samples and data. The Associate I is responsible for supporting key functional, tactical, and operational aspects of the QC Sample Control group at Biogen. Adhere to compliant cGMP documentation practices, possesses a fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions. Adherence to all cGMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. Able to work effectively within the group.
What You’ll Do
- Process validation, release, raw material, in-process and other related samples for QC testing
- Routinely assist with pulling samples for testing based on the Stability “Pull Calendar”
- Sample Maintenance
Who You Are
The candidate will posses strong skills with the ability to work well in a fast-paced organization.
- HS Diploma with 5 years of relevant experience
- AA/AS in Life Sciences with 2-3 years of relevant experience
- Bachelor's Degree with 1+ years of relevant experience
- Experience in cGMPs
- Consistent ability to perform independently, ability to direct and manage schedules, compliance with cGMP’s are required
- Occasional (rare) weekends are required
- Knowledge of LIMS (Labware)
- Prior experience with Aseptic Technique a plus
- Ability to work independently in all facets of position, time and stress management skills, multitasking, interpersonal and communication skills
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.