Quality Control Supervisor

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 revi...