Quality Control Lead

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We provide a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical devices, specialty chemical, and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System.

About the role

The Quality Control Lead is responsible for scheduling in-process samples, intermediate products, final products, and stability samples analytical analysis to support both product manufacturing and commercial product release needs. Serves as liaison between production, planning, business, and the QC department for analytical activities needs. The QC Lead also mentors QC Analysts to ensure department compliance with QC Laboratory Systems such as equipment maintenance, OOS Investigations, Inventory, and Activity Logbooks.

Responsibilities

• Provide leadership and guidance to the quality control team, including hands-on training and mentoring.
• Coordinate work assignments for raw materials, in-process, intermediates, and finished goods samples testing.
• Prioritize testing schedule to ensure efficient operation of the quality control department and adherence to KPIs.
• Foster a culture of accountability, collaboration, and continuous improvement within the team.
• Lead QC Analysts on laboratory inventory maintenance to ensure no impact to turnaround time (TAT). Assist on inventory sourcing along with the Procurement Department when necessary. Escalate any potential issues to the QC Manager in a timely manner.
• Independently perform equipment maintenance as well as equipment and software troubleshooting.
• Independently review QC data using both electronic systems and hard copy documentation, as well as QC Orders Completion.
• Report OOS results, compile required information, and independently complete laboratory investigation reports.
• Independently review, revise, and approve procedures and test methods.
• Maintain a safe, clean, and organized environment (5S) for all QC areas. Ensure adherence to the 5S audit schedule.
• Implement quality and continuous improvement initiatives, such as Six Sigma, Lean Manufacturing, or Total Quality Management principles.
• Engage cross-functional teams to implement best practices and foster a culture of continuous improvement.
• When required, perform routine analytical analysis using equipment such as volumetric glassware, balances, GC-MS, GC-FID, LC-DAD, LC-MS, NMR, TGA, DSC, and others.
• Serve as QC Manager designee for approval of QC-related investigations, protocols, reports, procedures, and instructions.

Requirements

• Bachelor’s Degree in Chemistry or related science field required.
• Six Sigma or related certification required; Auditor (CQA) or related certification preferred.
• At least five (5) years of experience working in an ISO 13485 or FDA GMP regulated environment required.
• Proven leadership abilities or training in coaching, mentoring, and team-building skills.
• Experience with quality control GMP documentation of testing results and assurance of laboratory data integrity and compliance required.
• Strong knowledge of analytical equipment, analytical methods, method validation, and data analysis required.
• Knowledge of compendial methods (e.g., USP, EP, ISO, ASTM) required; knowledge of ICH guidelines preferred.

Benefits

• Competitive wages and generous year-end bonus.
• Comprehensive medical plans with telemedicine, prescription, and vision coverage.
• Two dental plans.
• Healthcare, dependent care, and commuter flexible spending accounts.
• 401(k) with company match.
• Financial health and wellness with 1:1 coaching and rewards.
• Basic and supplemental life insurance.
• Accident, hospital indemnity, and critical illness insurance.
• Paid time off and paid parental leave.
• Short- and long-term disability.
• 9 paid holidays.

Must have legal authorization to work in the U.S. and will not require sponsorship. Polysciences is an equal opportunity employer and maintains a drug-free, tobacco-free workplace.