QC Auditor

Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D.

Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.

Cosette is headquartered in Bridgewater, NJ with 2 additional locations in the U.S. The South Plainfield, NJ office consists of an R&D Laboratory and other functional areas. The Lincolnton, NC site is a fully functioning, state of the art, manufacturing facility.

Innovating every day.

The purpose of this position is to review QA/QC documentation, to assess data compliance/validity with regulatory guidelines in the Quality Control Department, and ensure that all the work is performed and documented accurately, timely and in compliance with internal procedures and regulatory agencies.

• Provide technical support for the release of raw materials, finished products, and stability data.
• Ensure all recorded data is accurate, legible, complete, and documented in such a manner as to be understood by a 3rd party.
• Review all recorded QC data and assess it for compliance to applicable test methods, GDPs, and adherence to internal SOPs.
• Track and assist in resolution and close out of open and outstanding deviations, in validations, out of trend reports, and out of specification investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.
• Other duties as assigned by management

• BS or BA in Chemistry or related science with one year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc.).
• Prior experience (one year preferred) or ability to learn, FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.) as pertains to a QC Laboratory.

• Basic understanding of general chemistry principles.
• Proficient in mathematics.
• Ability to read and interpret technical documentation, such as Monographs, GTMs, and USP/BP Test Methods, Protocols, and FDA Guidance.
• Consistently audits basic electronic chromatography results analyses (i.e. active assays, IDs, isocratic analyses, etc.) for accuracy, completeness, compliance to GDPs and cGMPs and with no omissions or errors.

• USP
• Empower

• Safety Glasses
• Laboratory Coat
• Appropriate shoes and clothing
• This position requires minimal physical requirements. The incumbent is however, required to have manual dexterity and will be required to sit for hours using a computer.
• Ability to occasionally lift 50 pounds