(CW) Senior QC Analyst

Role Summary

The QC Analytical Senior Analyst is responsible for timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products in compliance with cGMP. They work independently on mastered assays and perform advanced assays for multiple products, documenting activities and identifying deviations from approved procedures. The role requires strong record-keeping, organizational, and written and verbal communication skills, and includes developing cGMP compliance expertise, supporting regulatory inspections, and training other staff.

Responsibilities

• Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines
• 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
• Evaluates data against defined criteria/specifications
• 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

Qualifications

• Required: 3+ years of experience in a cGMP/GLP laboratory
• Required: 2+ years hands-on experience in separation sciences (HPLC, UPLC, CE)
• Required: Ability to follow written instructions and to perform tasks with direct or minimal supervision
• Required: Strong leadership skills demonstrated through past work history
• Required: Use of a computer: Proficient in Windows, Microsoft Word, Excel
• Required: Good written and verbal communication skills
• Required: Attention to detail and strong documentation skills
• Required: Ability to contribute effectively in team environments and independently
• Preferred: 3-5 years of Quality Control laboratory experience
• Preferred: 3-5 years of hands-on experience in separation sciences (HPLC, UPLC, CE)

Education

• B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry)