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QA Data Reviewer I
New Brunswick, New Jersey · Biotech/PharmaceuticalAre you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a QA Data Reviewer I to join their New Brunswick, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Direct Hire
Pay Rate: DoE
Job Summary
Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
Area of Responsibility
Under the direction of QA management, this individual:
Qualifications
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
Direct Hire
Pay Rate: DoE
Job Summary
Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
Area of Responsibility
Under the direction of QA management, this individual:
- 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.
- Supports systems to ensure the successful completion of Departmental goals and objectives.
- Other tasks as assigned by the Manager.
Qualifications
- Minimum of a Bachelors.
- Minimum of three (3) years of experience in a pharmaceutical environment with a minimum two (2) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).
- Knowledge of pharmaceutical analysis.
- 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.
- Knowledge of USP, ICH, FDA, and DEA regulations.
- Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1