At our laboratory, we are looking for a skilled and experienced Quality Control Specialist to join our dedicated QC team. This is a hands-on role that requires close collaboration with production teams and direct reporting to the QC Lab Lead.
The ideal candidate will undergo structured training in the US and take ownership of QC testing and documentation from the outset.
Key responsibilities include:
* Performing analytical testing using HPLC, GC, and other techniques
* Managing and reviewing data using Empower
* Maintaining manual paper-based records, including logbooks and QC reports in compliance with SOPs
* Supporting validation activities, stability studies, and environmental monitoring programs
* Ensuring GMP-compliant documentation, accuracy, and data integrity at all times
* Maintaining, calibrating, and troubleshooting laboratory instruments to minimize downtime
* Participating in out-of-specification (OOS) investigations and CAPA activities
* Collaborating with production teams to align QC schedules with manufacturing needs
Requirements for this position include:
* A Bachelor's degree in Chemistry or a related scientific discipline
* Minimum of 2 years' hands-on QC or analytical laboratory experience in industry (pharma, biopharma, or regulated manufacturing)
* Technical competence in HPLC and GC; Empower experience preferred
* Strong documentation skills, including manual logbook and report writing
* Knowledge of USP/EP testing and FDA/ISO requirements
* Ability to work independently and within a small, collaborative team
* Excellent communication and interpersonal skills