QC Auditor

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. in Lincolnton, NC seeks a QA/QC Auditor I to review QA/QC documentation and ensure data compliance with regulatory guidelines. You will support release of materials, review QC data, and help close deviations in a fast-paced manufacturing setting.

The role requires a BS in Chemistry or related science with experience in regulated environments and familiarity with FDA regulations (cGMP, GDPs, USP/BP). Safety and procedural compliance are essential.

Qualifications

• BS or BA in Chemistry or related science with 1 year of auditing experience in a regulated environment (FDA, GLP).
• Familiarity with FDA regulations (cGMP, GDPs, USP/BP) for QC laboratory.
• Ability to read and interpret technical docs such as Monographs, GTMs, and USP/BP methods.

Responsibilities

• Provide technical support for release of raw materials, finished products, and stability data.
• Ensure all recorded data is accurate, legible, complete, and understandable by a 3rd party.
• Review recorded QC data for compliance to test methods, GDPs, and internal SOPs.
• Track and assist in resolution of deviations, invalidations, out of trend, and out of specification investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.
• Other duties as assigned by management

Skills

Attention to detail

Math proficiency

Documentation literacy

cGMP knowledge

Education

BS in Chemistry

Tools

USP

Empower

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

Equal Opportunity Employment

Cosette Pharmaceuticals, Inc. is committed to providing equal employment opportunity to all applicants and employees in all phases of our operations. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, sex, pregnancy, childbirth or related medical conditions, gender identity or expression, sexual orientation, marital status, domestic partnership, familial status, reproductive health decisions, status as a victim of domestic violence, stalking, or sexual assault, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, veteran status, liability for service in the United States armed forces, or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.