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.
