Quality Control Supervisor (Manufacturing)
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 device, 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 (QC) Supervisor leads a team of QC Analysts in the timely and compliant testing of raw materials, in-process samples, intermediates, final products, and stability samples. This role ensures that the QC Laboratory effectively supports manufacturing operations and commercial product release requirements, while maintaining compliance with ISO 13485:2016 and applicable sections of 21 CFR Part 820 (GMP). The QC Supervisor is responsible for maintaining the QC Laboratory in a constant state of audit readiness by ensuring adherence to all relevant regulatory, quality, and safety standards. Additionally, the QC Supervisor serves as a key QC representative for R&D initiatives and New Product Introductions (NPIs).
Essential Functions:
- Provide direct leadership, guidance, and mentorship to QC team members, including hands-on training and performance support.
- Foster a culture of accountability, collaboration, and continuous improvement within the QC team.
- Prioritize testing activities to align with production schedules and key performance indicators (KPIs).
- Manage laboratory inventory to prevent testing delays; collaborate with Procurement for sourcing and ERP system updates. Escalate any potential inventory risks that may impact turnaround time (TAT).
- Lead QC equipment qualification, calibration, and maintenance activities in collaboration with the Facilities Department. Act as primary approver for QC equipment and provide backup support for Analytical R&D (AR&D) equipment.
- Escalate to management when capital expenditures (CAPEX) are required to implement safety, efficiency, or compliance-related solutions within the QC laboratory.
- Review and approve QC analytical data in both electronic systems and hardcopy formats, ensuring compliance with ISO 13485:2016, 21 CFR Part 820, and 21 CFR Part 11 data integrity requirements.
- Monitor and trend Out-of-Specification (OOS) results, investigating root causes to support continuous improvement across QC, Production, and QA functions. Serves as primary QC Approver for OOS investigation reports.
- Ensure adherence to stability study protocols, manufacturing validation protocols, and test method validation execution in support of New Product Introductions (NPIs), coordinating with R&D and QA to meet project timelines and regulatory requirements.
- Serve as the document owner for QC department procedures. Independently review, revise, and approve protocols, SOPs, and test methods per document control policies.
- Support retain samples program within QC functions, ensuring proper documentation, storage conditions, and routine sampling in compliance with internal procedures and regulatory requirements.
- Ensures adherence to stability and test method validation testing execution to support NPI.
- Maintains and improves compliance with 5S standards for cleanliness, safety, and organization within all QC areas. Lead adherence to internal 5S audit schedules.
- Implement quality improvement initiatives including Lean, Six Sigma, and Total Quality Management (TQM) to drive operational excellence in the QC Laboratory.
- Represent QC in cross-functional meetings and during internal and external audits, inspections, and regulatory assessments.
Qualifications
Education Required: Bachelor's Degree
Certification(s): Specify preferred or required.
Bachelor's Degree in Chemistry or related science field required.
Six Sigma or related certification required.
Auditor (CQA) or related certification preferred.
Computer Skills Required: Specify preferred or required.
Proficiency with Adobe, Microsoft Word and, Excel.
Other qualifications:
- Minimum five (5) years of experience working in an ISO 13485:2016 or FDA GMP regulated environment required.
- Minimum two (2) years in a supervisory or leadership role required. Proven leadership abilities on training, mentoring, and team-building skills.
- Strong working knowledge of ISO 13485:2016, 21 CFR Part 820, and 21 CFR Part 11 required.
- Strong knowledge of analytical equipment, analytical methods, method validation and data analysis required.
- Proficiency with Microsoft Office and electronic analytical laboratory software (e.g., Open Lab or Empower) required.
- Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) required.
- Knowledge on ICH guidelines required.
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
3 PPO 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.
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