Associate III, Quality Control Chemistry
About The Position
The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards. Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues. Importantly, the Associate III is responsible for generating, communicating, and coordinating test results with key Chemistry customers, as appropriate, to support departmental, site, and global initiatives. Finally, the Associate III will have cross-departmental interaction with peers to ensure timely communication of issues to support QC and manufacturing initiatives.
Requirements
- Bachelor's degree or Associate's degree (+2 years lab experience) in biological/chemistry/life sciences
- HPLC experience
- Possess technical knowledge regarding Quality Control Chemistry release and stability methodology
- Demonstrated instrument/method troubleshooting skills
- Knowledge of FDA/EMEA regulations and compliance
Nice To Haves
- Prior GMP experience in industry, especially in QC Chemistry
- LC MS, HPLC, Dissolution, Karl Fischer, GC experience
- Previous work with small molecule or antisense oligonucleotides
- Solid presentation, oral and written communication skills
- Ability to communicate with peers and management
- Effective organizational skills
- Ability to multi-task and coordinate multiple activities in parallel
- Demonstrated problem solving skills
Responsibilities
- Performs release and stability testing, as needed.
- Performs sound technical review for data and documentation generated for or by QC Chemistry
- Authors or reviews investigational protocols, investigational reports, change control requests, validation protocols, and validation reports, etc.
- Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group
- Provides technical leadership through effective project management including laboratory investigations
- Support maintenance of laboratory systems to ensure data integrity
- Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Chemistry laboratory
- Actively provides leadership and mentoring as needed to aide in the development of their peers
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
Education Level
Associate degree
