QC Compliance Specialist - 2nd Shift

Job Responsibilities:

• Conduct comprehensive technical reviews of analytical and microbiological testing for finished products, in-process materials, raw materials, stability studies, and environmental samples. Ensure compliance with GMP standards, data integrity, and audit trail accuracy.
• Lead and drive laboratory investigations, deviations, and change controls, identifying root causes and implementing effective corrective and preventive actions (CAPAs).
• Serve as a subject matter expert (SME) for electronic QC database systems, ensuring laboratory data integrity and compliance with regulatory requirements.
• Author and revise technical documentation, including specifications, protocols, SOPs, and templates. Enhance analytical methods and procedural efficiency.
• Mentor and develop laboratory analysts, providing technical guidance on GMP principles, chromatographic/spectrographic techniques, and general analytical testing.
• Provide critical laboratory documentation and data to support regulatory filings, product import/export requirements, and site management needs.
• Monitor and analyze product trends, identifying out-of-trend results and potential quality concerns.
• Oversee and maintain the Site Stability Program, ensuring proper execution and compliance.
• Assess method reliability and contribute to the Product Quality Review (PQR) and Annual Product Review (APR) process.
• Represent the QC laboratory in regulatory and customer audits, ensuring readiness and compliance.
• Manage method transfers into the QC laboratory, coordinating with Quality Assurance (QA) and Quality Control (QC) teams for successful implementation.
• Lead and participate in continuous improvement projects focused on method enhancements and efficiency optimization.
• Support troubleshooting, repair, and calibration of laboratory instruments, ensuring operational reliability.
• Handle hazardous waste as required, attending annual training sessions and demonstrating competency through assessments.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or Life Sciences.
• 5-7 years of experience in a GMP-regulated environment.
• Strong technical knowledge of analytical testing, method development, and laboratory compliance.
• Proficiency in electronic laboratory systems (e.g., OpenLab) and data integrity principles.
• Experience in conducting investigations, implementing CAPAs, and managing change controls.
• Excellent technical writing, problem-solving, and mentorship skills.