Senior Quality Control Analyst, QC Technical Resources

Job Summary

Provides scientific and technical, support to the Quality Control Technical Service group while coordinating all aspects of the site's stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers, verifications, and qualifications activities.

Responsibilities

• Develop and maintain stability protocols, reports, and other related documentation to support the stability program.
• Manage stability chambers, including qualification, monitoring, and capacity planning.
• Ensure timely pull points, testing, data review, and reporting for all stability studies.
• Trend stability data, identify OOT/OOS signals, and support investigation related to stability samples
• Author, review, and revise QC SOPs, test methods, and technical documentation
• Develop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC.

Skills required

• Deep knowledge of GMP regulations and advanced laboratory techniques.
• Strong Knowledge of in Empower and Open Lab chromatography software.
• Strong understanding of stability program requirements (ICH Q1A-Q1E).
• Familiarity with GMP, data integrity principles, and regulatory expectations.
• Strong organizational skills and ability to manage multiple studies and timelines.
• Excellent documentation, communication, and cross-functional collaboration abilities.
• Knowledge of method validation or lifecycle management.
• Ability to analyze data trends and contribute to technical investigations.
• Familiarity with regulatory guidelines (ICH, FDA, EMA)
• Maintain audit-ready documentation and support internal and external inspections.
• Well-organized, capable of multi-tasking and working on complex problems with sound scientific judgement
• Excellent data analysis skills with attention to detail and interpretation of results
• Excellent written and oral communication skills
• Experience with computer software such as WORD, EXCEL and chromatographic workstation systems

Education and experience

• BS in Chemistry, Biochemistry, Analytical Chemistry or related field
• Minimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotech

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times

Compensation

The base salary for this role starts at $114,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.

Equal Opportunity Employer

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