QC Lab Lead - GMP Analytics & Compliance

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 85,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions seeks a QC Supervisor in Sellersville, PA to lead a team of 4–5 analysts performing analytical chemistry and microbiology tests across raw materials, finished products, and environmental samples. You will ensure GMP-compliant operations, investigations, and data reviews to drive quality and regulatory readiness.

The role requires a Bachelor's in a related science, 7+ years in GMP labs, and 5+ years in leadership, with hands‑on expertise in HPLC/UPLC/GC and experience

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related 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.

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.
• Lead and manage cleaning validation and cleaning verification programs.
• Facilitate communication and testing activities with external laboratories.
• Perform data review and auditing to support lot disposition decisions.
• Lead OOS/OOT investigations, CAPAs, and change controls.
• Support laboratory inspection readiness and regulatory compliance initiatives.
• Support Empower, LIMS, and TrackWise systems administration.
• 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 cross-functional project teams.

Skills

Leadership

Analytical skills

Communication

Data integrity

Regulatory knowledge

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

ICP-MS

Empower

LIMS

TrackWise

Job description

Piramal Pharma Solutions seeks a QC Supervisor in Sellersville, PA to lead a team of 4–5 analysts performing analytical chemistry and microbiology tests across raw materials, finished products, and environmental samples. You will ensure GMP-compliant operations, investigations, and data reviews to drive quality and regulatory readiness.

The role requires a Bachelor's in a related science, 7+ years in GMP labs, and 5+ years in leadership, with hands‑on expertise in HPLC/UPLC/GC and experience