Quality Control Analyst II

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.

Requirements

• 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.

Benefits

• Paid Time Off