The Quality Control Analyst II ensures quality and compliance through testing and validations, supports laboratory operations, and contributes to data review and regulatory activities.
The Quality Control Operations (QCO) Analyst II Contractor plays a key role in ensuring the highest standards of quality and compliance across development, manufacturing, and commercialization activities. This position performs routine and non‑routine testing, supports method transfers and validation activities, contributes to investigations and data trending, and assists with daily laboratory operations. The role is essential in driving QC efficiency, accuracy, and continuous improvement.
Key Responsibilities
- Perform routine and non‑routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in‑process samples, product release, and stability studies in accordance with SOPs.
- Support weekend laboratory operations and maintain up‑to‑date training records.
- Assist with laboratory equipment maintenance, inventory management, reagent preparation, and sample handling.
- Review analytical data in a timely manner and serve as a qualified data reviewer.
- Execute operational assignments including raw material processes, environmental monitoring, and in‑process testing.
- Contribute to the revision and creation of controlled documents such as SOPs, work instructions, and test methods.
- Adhere to internal policies, SOPs, and regulatory requirements including GMP, GLP, and ICH guidelines.
- Participate in continuous improvement initiatives and collaborate cross‑functionally to enhance QC operations.
- Support regulatory submissions, inspection readiness activities, and internal/external audits.
Requirements
Qualifications:
- B.S. in Chemistry, Biology, Biochemistry, or a related scientific discipline.
- 4–8 years of pharmaceutical or biotech experience in a GMP QC environment or equivalent.
- Experience with method transfer and implementation; familiarity with method lifecycle management is preferred.
- Strong technical writing, data analysis, problem‑solving, and organizational skills.
- Excellent communication skills and ability to work effectively in a team‑oriented environment.
- Proficiency with LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred.
Benefits
- Weekend Shift Role
- 10-month contract with possible extension
Top Skills
Hplc
Labware Lims
Excel
Microsoft Powerpoint
Microsoft Word
Uplc
BioPharma Consulting JAD Group Cambridge, Massachusetts, USA Office
PO Box 425233, Cambridge, MASSACHUSETTS, United States, 02142
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