QC Analyst III (Pharma)

Job Summary

The QC Analyst III is responsible for performing advanced analytical testing, data review, method validation, and laboratory investigations to support product quality and regulatory compliance. This role provides technical leadership for analytical activities, stability programs, and continuous improvement initiatives while collaborating with cross-functional teams to ensure timely and compliant laboratory operations.

Responsibilities

• Perform complex analytical testing and data evaluation using techniques such as HPLC, ELISA, and other applicable methodologies.
• Troubleshoot laboratory equipment and instrumentation issues, implement corrective actions, and communicate resolutions to management.
• Participate in and support analytical method validations, verifications, and transfers.
• Evaluate and trend analytical data to identify quality issues, process improvements, and potential risks.
• Lead and support Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical result investigations, including root cause analysis, product impact assessments, and implementation of CAPAs.
• Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, and other departments to coordinate testing activities and communicate results.
• Career Development Coordinate testing activities performed by external contract laboratories, including raw material, in-process, and finished product testing.
• Maintain accurate, complete, and compliant laboratory records and documentation.
• Author, execute, review, and approve SOPs, protocols, reports, investigations, change controls, risk assessments, and data summaries.
• Develop, revise, and optimize analytical methods, testing procedures, and laboratory documentation.
• Train laboratory personnel on analytical techniques, procedures, and compliance requirements.
• Support laboratory equipment maintenance, qualification, calibration, and general upkeep activities.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline required; advanced degree preferred.
• Minimum 5–8 years of experience in a pharmaceutical, biotechnology, or other regulated laboratory environment.
• Demonstrated experience performing analytical testing using HPLC, ELISA, and other laboratory techniques.
• Experience with analytical method validation, method transfer, and stability testing programs.
• Strong understanding of cGMP regulations and applicable FDA, ICH, USP, and other regulatory requirements.
• Experience conducting OOS/OOT investigations, root cause analysis, risk assessments, and CAPA implementation.
• Proven ability to author and review technical documents, including SOPs, protocols, reports, and investigations.
• Excellent organizational skills with the ability to manage multiple priorities and meet deadlines.
• Strong verbal and written communication skills, including the ability to present technical information to diverse audiences.
• Demonstrated leadership experience, including project management, mentoring, and training of laboratory personnel.
• Proficiency with Microsoft Office applications and data analysis tools.
• Ability to work independently and collaboratively within a cross-functional team environment.