Job Description A fantastic opportunity has arisen for a Lead Tech, Quality Control at our state‑of‑the‑art quality operations laboratory which manufactures and tests the largest‑selling biologic and the largest‑selling vaccine product. The site is a strategic manufacturing hub for biologics and vaccines.
This role will report directly to the QC Manager and help expand the laboratory. The lab operates 2‑cycle and 4‑cycle shifts, and occasional travel may be required for training purposes.
Responsibilities Perform and review all routine and non‑routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
Participate in method transfers and provide technical expertise; act as method SME while driving continuous improvements and conducting root cause analysis on system failures and substandard equipment performance using tools such as FMEA, Fishbone diagrams, 5‑why’s, etc.
Act as lead of the QC team performing allocated testing and laboratory duties and leading troubleshooting activities.
Perform analytical techniques including HPLC (HIC, CE, IEX, HP-SEC), capillary electrophoresis, ELISA, cell‑based assays and other compendial test methods in compliance with GMP; mentor junior members of the team.
Peer‑review and approve testing documentation, ensuring data integrity compliance and QC right‑first‑time KPIs are achieved.
Lead laboratory aspects of out‑of‑specification (OOS) investigations.
Drive completion of all assigned data processing and review across the lab team.
Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
Ensure that all quality systems within the department are adhered to on a daily basis.
Ensure timely completion of laboratory investigation reports and deviations through site procedures.
Lead QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations, etc.
Participate in timely generation of trend data, investigations, nonconformances, validation protocols, and reports supporting method validation and equipment qualification.
Take the lead in internal and external audits and inspections, serving as audit participant for assigned areas of responsibility, answering audit comments where appropriate.
Work as directed by the QC Manager / Associate Director according to company safety policies, cGMP and cGLP; drive compliance with global policies, procedures, guidelines and regulatory requirements.
Qualifications Bachelor’s degree or higher preferred; ideally in Analytical Chemistry, Biochemistry or a related discipline.
2‑3 years of experience in a pharmaceutical laboratory, preferably with HPLC experience and relevant systems/software; core to the role is performing testing of samples to support the release of key drug products.
Good working knowledge of HPLC systems and software is desirable.
Strong knowledge of cGMP, GLP and quality management systems.
Experience with HPLC, capillary electrophoresis, ELISA and other compendial test methods in GMP compliance.
Demonstrated ability to peer‑review documentation and ensure data integrity.
Experience with OOS investigations, data analysis, root cause analysis and continuous improvement.
Familiarity with internal and external audit processes.
Excellent communication, team leadership and mentorship skills.
As an equal‑opportunity employer, we are proud to embrace diversity and inclusion.
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