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QC Coordinator

Johnson Matthey

This is a Full-time position in West Deptford, NJ posted January 12, 2022.

Johnson Matthey (‘JM’) is a global leader in science that enables a cleaner and healthier world.

With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products.

Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources.

Today more than 14,000 Johnson Matthey professionals collaborate with our network of customers and partners to make a real difference to the world around us.

Principally responsible for leading the reference materials program including performing qualification testing not limited to: HPLC, KF, FTIR, GC, UV-Vis, and TGA to ensure site support and customer requirements are met.

Maintains QC controlled substance sample tracking inventory and leads destruction and inventory efforts.

Evaluates compendia updates for site impact and coordinates implementation.

Key Responsibilities

Apply scientific knowledge to perform qualification of reference materials following all Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs).

Schedule and conduct analyses and interpret results accurately and defensibly for reference standards.

Review data, write associated reports, and issue CofT or CofA as required.

Maintain inventory of reference standards and markers.

Follow plant manufacture and stability testing schedule to ensure availability of needed reference material.

Keep current with regulatory and requirements and trends as related to reference standards.

Shipment of reference materials for client requests and external laboratory testing.

Work together with EH&S for the creation of SDS for new reference material.

Maintain a working knowledge of DEA and import/export procedures and requirements for controlled substances.

Maintain controlled substance records in both paper and LIMS systems as appropriate.

Direct controlled substance inventory/discard process.

Provide timely documentation to site DEA Specialist.

Review quarterly compendia update newsletter and initiate MOCs for site impact.

Contribute to regulatory submissions and responses.

Collaborate with Analytical Development, Chemical Development, Business Development, Commercial, Regulatory, and Project Management departments along with other JM sites and customers.

Revise/create SOPs.

Contribute to laboratory organization and compliance/audit readiness.

Participate in quality audits with FDA, other regulatory agencies and customers.

Other duties as assigned.

Are you the ideal candidate?

BS in Chemistry or equivalent with at least 5 years related experience in a pharmaceutical Quality Control environment.

Experience with common analytical techniques such as: HPLC, GC, UV, pH meter, KF, FTIR.

Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.

Ability to write clear and concise technical reports.

Ability to work independently with minimal supervision and in a team environment.

Good written and verbal communication skills.

Experience communicating effectively to management.

Good understanding of Microsoft Office.

Demonstrate ability to exercise good judgment and make decisions quickly.

Valued

Experience in establishing integrated plans with resource and task constraints.

Experience with common analytical techniques such as: HPLC, GC, LC-MS.

Experience with Empower, Labware LIMS, ChemDraw software.

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