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Compliance Specialist

Actalent

11/30/2021

Posting ID: JP-002483277

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New Brunswick, New Jersey
Full Time
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I have a Compliance Associate II/III opportunity available right now! This position can hold interviews as soon as possible and offers a competitive salary.

Description:

• Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.

• Demonstrates a thorough knowledge of approved SOP’s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.

• Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.

• Assists in preparing technical documentation including test reports, analytical test procedures, and change controls.

• Supports systems to ensure the successful completion of Departmental goals and objectives.

• Have thorough knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.

• Performs other duties as assigned.

Additional Skills & Qualifications:

• B.S. or advanced degree in chemistry or a related science with a minimum of 1-4 years experience and a fundamental knowledge of pharmaceutical analysis is preferred.

• Good written and oral communication skills. Documented ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories. Good understanding of EHS and OSHA safety guidelines.

• Experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry)

• Knowledge of USP, ICH, FDA, and DEA regulations.

• Must be able to work independently.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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