Job Title
Quality Control Supervisor
Job Description
Piramal Pharma Solutions is seeking an experienced and motivated QC Supervisor to lead a team of Quality Control analysts in the Sellersville, PA facility. This role is responsible for supervising laboratory operations, ensuring compliance with GMP requirements, supporting laboratory investigations, and driving operational excellence within the Quality Control department. The QC Supervisor oversees a team of approximately 4-5 analysts performing analytical chemistry and microbiological testing on raw materials, finished products, environmental monitoring samples, cleaning validation samples, and stability studies.
Key Responsibilities- Supervise daily activities of approximately 4-5 QC analysts.
- Plan, coordinate, and prioritize laboratory testing activities to support manufacturing and supply chain schedules.
- Review analytical data generated from HPLC, UPLC, GC, and ICP-MS testing.
- Ensure testing is performed in accordance with approved SOPs, USP, EP and regulatory requirements.
- Coordinate sampling, testing, and laboratory support activities for production operations.
- Manage cleaning validation and cleaning verification testing programs.
- Facilitate communication and testing activities with external laboratories.
- Perform data review and auditing to support lot disposition decisions.
- Lead and document OOS, OOT, deviation investigations, CAPAs, and change controls.
- Support laboratory inspection readiness and regulatory compliance initiatives.
- Support Empower, LIMS, and TrackWise systems administration activities.
- Prepare, review, and approve validation and verification protocols and reports.
- Maintain and periodically review departmental SOPs.
- Provide training, coaching, performance management, and development for QC analysts.
- Participate in site quality initiatives and represent QC on cross-functional project teams.
- Other duties as deemed necessary
Education & Experience- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related scientific discipline.
- Minimum 7 years of technical laboratory experience in a GMP-regulated environment.
- Minimum 5 years of leadership or supervisory experience.
- Experience with analytical chemistry and/or microbiological testing.
- Hands-on experience with HPLC, UPLC, and GC instrumentation.
- Knowledge of GMP, FDA, ICH, and USP requirements.
- Experience with Empower, LIMS, and TrackWise preferred.
Knowledge, Skills & Abilities- Strong leadership and team development skills.
- Excellent written, verbal, and interpersonal communication skills.
- Strong analytical and problem-solving capabilities.
- Proficiency in Microsoft Office applications.
- Knowledge of data integrity principles and laboratory compliance requirements.
- Ability to manage multiple priorities in a fast-paced environment.
