Quality Control Lead

Polysciences, Inc.; Warrington Township (Bucks County); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical Plans

Dental Plans

401(k) with company match

Paid Time Off

Paid Holidays

Life Insurance

Disability Insurance

Flexible Spending Accounts

Job summary

Polysciences, Inc. is seeking a seasoned Quality Control Lead to oversee QC activities across analytical testing for manufacturing and product release. You will mentor analysts, manage testing schedules, and ensure data integrity and compliance with ISO 13485 and FDA GMP standards.

The role emphasizes leadership, process improvement, and cross-functional collaboration with production, planning, and procurement to maintain quality and drive efficiency in a fast-paced lab environment.

Qualifications

• Bachelor’s Degree in Chemistry or related science field required.
• Six Sigma or related certification required.
• At least five (5) years of experience in ISO 13485 or FDA GMP environment.
• Proven leadership abilities and experience coaching teams.
• Experience with GMP documentation and data integrity.

Responsibilities

• Provide leadership and mentoring to QC team.
• Coordinate testing schedules for raw materials, in-process, intermediates, and finished goods.
• Maintain 5S and a safe, organized QC environment.
• Lead investigations of OOS and deviations with timely reporting.
• Review and approve QC procedures and test methods.
• Collaborate with production, planning, and procurement to ensure timely analysis.
• Drive continuous improvement initiatives (Six Sigma, Lean, TQM).
• Oversee laboratory equipment maintenance and data integrity.

Skills

Leadership

Six Sigma

Quality control

Coaching

Education

Bachelor’s Degree in Chemistry

Tools

GC-MS

GC-FID

LC-DAD

LC-MS

NMR

TGA

DSC

Job description

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer 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. We believe the best scientific innovations are built through collaborations.

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 with the QC department for analytical activities needs. QC Lead is also responsible to mentor QC Analysts to ensure department’s compliance to the QC Laboratory Systems such as equipment maintenance, OOS Investigations, Inventory, Activity Logbooks, etc.

Essential Functions

• Provide leadership and guidance to the quality control team, including on-hands 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
• Leads other QC Analysts on laboratory inventory maintenance to ensure no impact to TAT. Assist on inventory sourcing along with Procurement Department when necessary. Escalates any potential issues to QC Manager in a timely manner.
• Independently performs equipment maintenance as well as equipment and software troubleshooting.
• Independently reviews of QC data, using both electronic systems and hard copy documentation as well as QC Orders Completion.
• Reports OOS results, compiles required information and independently completes laboratory investigation report
• Independently review, revise, and approve procedures and test methods
• Maintains a safe, clean, and organized environment (5S) for all QC areas. Ensures adherence to 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 the following equipment: volumetric glassware, balances, GC-MS, GC-FID, LC-DAD, LC-MS, NMR, TGA, DSC and others as required.
• Serves as QC Manager designee for approval, QC related investigations, protocols, reports, procedures and instructions.

Qualifications

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 on 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 (ie. USP, EP, ISO, ASTM) required.
• Knowledge on ICH guidelines preferred.

What We Offer

Culture

• Great people
• Peer to Peer Recognition
• Broader, hands-on work experience
• Clean and Modern Equipment & Labs
• Fun company events

Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

• Medical Plans with Telemedicine, Rx, & Vision
• 2 Dental Plans
• Healthcare, Dependent care, & Commuter Flexible Spending Accounts
• 401(k) with company match
• Financial Health & Wellness w/1:1 Coaching & Rewards
• Basic & Supplemental Life Insurance
• Accident, Hospital Indemnity, & Critical Illness
• Paid Time Off
• Paid Parental Leave
• Short & Long-term Disability
• 9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.

Find us here Poly 424