QC Analyst – Quality Operations Laboratory
Join a growing and collaborative Quality Operations Laboratory team supporting the analysis of biologics, vaccines, and pharmaceutical products within a modern, highly regulated manufacturing environment. This role offers the opportunity to work in a state‑of‑the‑art facility focused on commercial testing, analytical method transfer, and validation activities.
The QC Analyst / Senior QC Technician will report to the QC Manager and play a key role in laboratory expansion, routine testing, and ensuring compliance with GMP and quality standards.
Shift Patterns This role operates on two different shift models , and positions are available across both:
2-Cycle Shift (e.g. days/evenings rotation)
4-Cycle Shift (including days, nights, and weekends)
Flexibility for shift work is essential.
Key Responsibilities Perform laboratory testing in accordance with cGMP, cGLP, and site procedures.
Execute analytical testing using techniques such as HPLC (HIC, IEX, HP-SEC), Capillary Electrophoresis , and compendial methods.
Support analytical method transfer, validation, and routine commercial testing .
Accurately complete and review laboratory documentation ensuring data integrity (ALCOA+) and Right First Time (RFT) principles.
Participate in Tier 1 meetings , communicating testing progress, deviations, and issues.
Assist in OOS (Out of Specification) investigations and laboratory deviations.
Contribute to SOP writing, revision, and training documentation .
Support audit and inspection readiness , including participation as an auditee.
Drive continuous improvement initiatives , including root cause analysis (e.g. 5 Whys, Fishbone, FMEA).
Work collaboratively with cross-functional teams to maintain a safe, compliant, and high-performing laboratory environment.
Requirements Bachelor’s Degree (or higher) in Analytical Chemistry, Biochemistry , or a related scientific discipline.
3-4 years’ experience in a GMP-regulated pharmaceutical laboratory.
Hands‑on experience with HPLC systems and associated software is strongly preferred.
Good understanding of cGMP, GLP, and Quality Management Systems .
Experience with laboratory investigations, LIMS, and documentation practices is desirable.
Strong attention to detail, problem‑solving skills, and ability to work in a team environment.
Additional Information Occasional travel may be required for training or project support.
Opportunity to work in a highly advanced manufacturing and laboratory environment.
Strong focus on employee development, collaboration, and continuous improvement.
Key Skills Analytical Method Transfer
GMP Compliance & Laboratory Operations
HPLC & Analytical Techniques
LIMS & Data Integrity
OOS & Deviation Investigations
SOPs & Technical Documentation
Quality Control & Testing
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