Quality Control Lead

Polysciences, Inc.•Warrington Township, PA

2d•$87,700 - $106,200•Onsite

About The Position

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, bioproprocessing, 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.

Requirements

Bachelor’s Degree in Chemistry or related science field required.
Six Sigma or related certification required.
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.
Proficiency with Adobe, Microsoft Word and, Excel.
Must have legal authorization to work in the US and will not require sponsorship.

Nice To Haves

Auditor (CQA) or related certification preferred.
Knowledge on ICH guidelines preferred.

Responsibilities

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.