QC Auditor at Cosette Pharmaceuticals, Inc. in Lincolnton, NC (On-Site)

Job description

• 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.

Responsibilities

• • 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, invalidations, 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

Requirements

• • 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.
• • Empower

Skills

Required

• Proficient in mathematics