QC Team Leader
Morgan McKinley Limerick
Job Title: QC Team Lead
Position Summary:
The Team Lead is responsible for overseeing daily operations and supervising a team of analysts within the chromatography section of a laboratory. This role ensures that testing is being delivered with high quality, in full compliance with applicable regulatory standards (e.g., cGMP, ISO 17025), and within project timelines.The Team Lead will be a subject matter expert in chromatographic techniques, manage resources, support client communications, and help drive continuous improvement initiatives.
Key Responsibilities:
- Supervise, coach, and support a team of chromatography analysts and technicians.
- Manage scheduling, resource allocation, and prioritization of sample analysis in alignment with project deadlines and client needs.
- Provide technical guidance and mentoring in chromatographic methods and troubleshooting.
- Oversee and participate in routine and non-routine chromatographic testing of raw materials, intermediates, finished products, and stability samples using HPLC, GC, GC-MS, IC and other techniques.
- Ensure testing is performed according to validated methods, standard operating procedures (SOPs), and regulatory guidelines.
- Participate in method development, validation, and transfer projects as needed.
- Ensure all work complies with current Good Manufacturing Practices (cGMP), ISO 17025, client specifications, and internal quality systems.
- Review analytical data and documentation for completeness, accuracy, and adherence to protocols.
- Lead or support investigations related to out-of-specification (OOS) results, deviations, and CAPAs.
- Support internal and external audits and regulatory inspections.
- Assist in drafting and reviewing technical reports and certificates of analysis.
- Drive continuous improvement in lab efficiency, turnaround time, and analytical robustness.
- Support implementation of lean lab practices and digital systems.
- Ensure a safe working environment and adherence to all environmental, health, and safety (EHS) regulations.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
- 5+ years of experience in a cGMP or ISO-regulated analytical laboratory, with strong expertise in chromatographic techniques.
- Minimum 1-2 years in a supervisory or team lead role in a laboratory.
- Demonstrated experience with method validation and regulatory compliance.
- Hands-on proficiency with HPLC, GC, GC-MS, IC and related data Systems.
- Strong knowledge of cGMP, USP/EP/JP methods, ICH guidelines, and ISO 17025 standards.
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The Team Lead, Analytical Laboratory will be required to coordinate and supervise all activities involved in the running of an efficient and effective analytical laboratory.
Reporting to: Manager, Analytical Laboratory
Find out more...