QC Auditor

cosettepharma; Lincolnton (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Cosette Pharmaceuticals, a US-based manufacturing site, is seeking a QA/QC Auditor to review QA/QC documentation and assess data compliance with regulatory guidelines in the Quality Control Department. The role focuses on releasing materials and data integrity, with emphasis on GDPs and cGMPs.

The candidate will audit data, track deviations and investigations, and maintain training tools for Auditor I, ensuring timely and accurate documentation in a fast-paced laboratory setting.

Qualifications

• BS or BA in Chemistry or related science with one year of regulated environment auditing experience (FDA, GLP, etc).
• Familiarity with FDA regulations (cGMP, GDPs, USP/BP) as pertains to QC Laboratory.
• Ability to read and interpret technical documentation (Monographs, GTMs, USP/BP Test Methods).
• Proficient in mathematics and data interpretation; attention to detail required.

Responsibilities

• Provide technical support for release of raw materials, finished products, and stability data.
• Review all recorded QC data for compliance to test methods, GDPs, and internal SOPs.
• Track and assist in resolution/closure of deviations, invalidations, out of trend reports, and out of specification investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.
• Audit laboratory documentation for accuracy, legibility, and completeness.
• Other duties as assigned by management

Skills

Documentation auditing

Regulatory compliance

Data interpretation

General chemistry

Mathematics proficiency

Reading technical docs

Education

BS/BA in Chemistry or related science

Tools

Empower

USP

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.

Basic Purpose:

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.

Essential Functions and 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

Knowledge, Skills, Qualifications and Physical Requirements:

Education/Training/Work Experience:

• 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.

Specialized Knowledge and Skills:

• 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.

Equipment and Applications:

• USP
• Empower

Work Environment and Physical Demands:

• 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