Quality Control Analyst

The QC Analytical Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.

• Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. General cGMP lab experience at the Analyst level.
• Works independently on assays they have mastered.
• Develops and maintains proficiency in a broad range of test methods.
• Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations.
• Actively applies knowledge in non‑routine situations using a thorough understanding of the work processes and practices.
• Identifies key issues in complex situations, analyzes problems, and makes sound decisions.
• Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned.
• Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise.
• Holds self and others accountable for adherence to department and company policies and practices.
• Maintains a safety and quality focused culture.

• B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).
• 1‑2+ years of experience in a cGMP/GLP laboratory.
• 1‑2+ years hands‑on experience in separation sciences (HPLC, UPLC, CE).
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Strong leadership skills demonstrated through past work history.
• Use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written and verbal communication skills.
• Attention to detail and strong documentation skills.
• Ability to contribute effectively in team environments and independently.
• 1‑2+ years of Quality Control laboratory experience preferred.
• 1‑2+ years of hands‑on experience in separation sciences (HPLC, UPLC, CE) preferred.