Senior Quality Control Analyst

About the role

Perform chemical testing of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in support of Good Manufacturing Practices (GMP) in-process, production, and stability testing. Utilize common analytical techniques such as HPLC, GC, LC-MS, KF, FTIR, NMR, and wet chemistry methods. Execute advanced analysis, and project management with minimal supervision. Troubleshoot technical problems with equipment and methods. Own Deviations and Corrective and Preventive Actions (CAPA) and perform root cause analysis. Share knowledge and information with other members of staff.

Core Responsibilities

• Independently deliver experimental output with a high degree of scientific integrity, both on time and on target, with a focus on quality.
• Independently create, maintain, analyze and/or update QC data following established methods and relevant specifications.
• Contribute to Continuous Improvement in the optimization of test methods and Quality Control (QC) processes.
• Train other staff on test methods and QC operations.
• Provide guidance to QC team members and other departments regarding technical or compliance topics.
• Prepares high-quality written documents including generation and revision of Standard Operating Procedures (SOPs), test methods, and other GMP documents.
• Own Quality Management Systems (QMS) records (i.e., deviations, CAPA, root cause analysis etc.) and drive toward completion.
• Manages data by following established procedures, standards and processes. Uses the concepts of ALCOA+ to maintain Data Integrity.

Qualifications

• BS in Chemistry, or equivalent, with 5+ years related experience -OR- MS in Chemistry or equivalent with 2+ years related experience
• Routine use of common analytical techniques such as HPLC/UPLC, GC, NMR, UV-Vis, pH meter, KF, FTIR, or Refractive index
• Maintain and troubleshoot laboratory equipment
• Experience with more advanced analytical techniques as required
• Previous GMP experience

Pay

The salary range for this role is $35/hr-$45/hr. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

Schedule

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.