Quality control Analyst

Qualifications

• Strong attention to detail and organizational skills
• Ability to follow instructions and GMP procedures accurately
• Ability to work independently and manage routine laboratory tasks with minimal supervision
• Comfortable performing routine and repetitive laboratory and documentation activities
• Strong time management skills and ability to support multiple priorities simultaneously
• at least 1–2 years of laboratory experience. (GMP QC laboratory or pharmaceutical industry experience preferred)
• Previous experience in a fast‑paced GMP QC laboratory environment preferred
• Basic exposure to HPLC, pH, Density, Osmolality, FT-IR, analytical balances, micropipettes, or analytical laboratory testing strongly preferred
• Familiarity with ICH, USP, 21
  
  CFR Part 210, and 211 preferred

• Support routine QC laboratory testing using pH, Osmolality, FT-IR, for in-process, finished product, and stability samples testing.
• Assist with sample management activities including but not limited to sample login, labeling, tracking, storage, and shipment coordination
• Support stability program execution including sample pulls, submissions, inventory management, and tracking activities
• Perform accurate documentation and data recording in accordance with cGMP, ALCOA+, and data integrity requirements
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records in an audit‑ready state
• Assist with laboratory investigations including OOS results, deviations, invalid assays, and other quality system activities
• Support laboratory maintenance, calibration, housekeeping, and audit readiness activities
• Work cross‑functionally with QA, Manufacturing, Stability, Microbiology and external laboratories to support testing timelines and operational priorities
• Follow approved SOPs, test methods, and other GMP laboratory procedures with minimal supervision
• Perform self‑review of data and documentation for accuracy and completeness prior to submission for secondary review
• Adapt quickly to changing priorities, urgent sample requests, and fluctuating laboratory workload