Chemistry Data Reviewer

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. The individual should be familiar with a variety of the position's concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks. Expected to make decisions based on experience and technical knowledge.

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 and computerized system QC data and assess it for compliance to applicable test methods, GDPs, and adherence to internal SOPs.
• Understands implications for non-compliant data. Follow internal SOPs for notifications and investigations in compliance meeting established time requirements for stability, FP, OOA/OOS data, etc.
• Complete Train the Trainer Program. Track and complete Training Guidelines and Training Effectiveness Tools.
• Discuss and improve the laboratory operation of documentation tracking system.
• Track and assist in resolution and close out of open and outstanding deviations, invalidations, out of trend reports, quality incidents, and out of specification investigations.
• 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 two years of experience auditing laboratory documentation in an FDA regulated environment and one year of QC Laboratory experience.
• Two years' experience using and/or following USP, BP, CFR21, cGMP, GDPs, and other FDA requirements associated with QC Laboratory.
• Experience training peers.

Specialized Knowledge and Skills:
• Advanced understanding of chemistry principles, including analyses associated with GC, HPLC, FTIR, UV/VIS instrumentation.
• Proficient in mathematics.
• Ability to assess auditing process and recommend changes for improvements.
• Consistently audits advanced Empower analyses (i.e. related compounds, gradients, advanced processing, etc.) for accuracy, completeness, compliance to GDPs and cGMPs and with no omissions or errors.
• Ability to read and interpret technical documentation, such as Monogragphs, GTMs, USP/BP Test Methods, Protocols, and FDA Guidances.
• Audits with a thorough understanding of processing and reporting degradant data, including a review of practices for interpreting QL, ND, and synthetic/process impurity references.

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

Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. 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, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, 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.

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