Regulatory Affairs / Quality Assurance Manager (Somerset, New Jersey)

Regulatory Affairs / Quality Assurance Manager (Somerset, New Jersey)

REGULATORY AFFAIRS / QUALITY ASSURANCE MANAGER

We are a leading national distributor of a wide array of chemicals for the Food, Pharmaceutical, Nutraceutical, Personal Care and Industrial markets.

Currently we have an opening for an experienced RA / QA Manager in our central Jersey facility.

The RA/OA manager will lead and grow many areas of Quality Management System. RA/OA will interface with regulatory authorities, raw material suppliers and customers alike in the pursuit of our quality goals. A wide degree of creativity and knowledge will be required. The RA/OA manager will rely on extensive experience and judgment to plan, improve and accomplish quality related tasks. RA/OA functions as part of our Quality team to integrate cGMP and GLP requirements throughout the company and the Quality Control laboratory. Some job functions are shared or overlap among other quality team members providing full support in a multi-department, cross-functional environment.
Primary Job Functions:
Liaison with raw material suppliers and customers as required ensuring regulatory needs are met. Provides support to sales department; periodically meet with customers attend trade shows. Coordinates compliance with federal regulations ( FDA, DEA, OSHA - GHS, DOT, EPA etc. ) as they relate to purchasing, storage, repackaging, labeling, transportation and sales of chemicals.
Follows Interprets changing trends regulations as they apply to company business concerns. Ensures and guides compliance with federal international guidelines.
Monitors regulated chemical lists to ensure chemical inventory is in compliance with requirements. e.g., DEA list I II precursors, Controlled substances
Conducts electronic chemical submissions to FDA in accordance with federal requirements.
Ensures that submissions of products are in accordance with approved FDA ICH guidelines. Performs all Company business in accordance with regulations and Company policies and procedures
Performs internal external quality audits as per FDA, ISO, and ICH guidelines.
Help to guide implementation of audit corrective measures.
As part of the quality team; prepares, implements, maintains, edits and reviews SOP's company manuals e.g., Quality Manual, HACCP, Chemical Safety Plan, etc.
Participates in CAPA quality and complaint investigations and report preparation.
Performs inspection testing of raw materials, components finished goods as necessary during investigations or when staff limitations mandate.
Education/Qualification/Experience Requirements:
Min. BA/BS, preferably in Chemistry or biochemistry
Min. 6- 10 years pharmaceutical/biotechnology personal care industry experience and / or Chemical Distributor Experience.
Assurance Quality Control experience Min. 2 years' experience preparing conducting FDA chemical submissions. Experience working in GLP validated laboratory
Experience understanding of applicable Domestic Global associated regulations pathways. Hands on laboratory monograph testing experience. E.g., with USP, NF, FCC, ASTM testing methods

Please send resume to Attn: HR Department.