Data Reviewer III Job at ClinLab Staffing, New Brunswick, NJ

VWE1cHErUkVZVThieVJWRzR1ZFNlNktZTFE9PQ==
  • ClinLab Staffing
  • New Brunswick, NJ

Job Description

Data Reviewer III—New Brunswick, NJ

With minimal direction from 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.
  • Minimum of a Bachelors.
  • Extensive 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.
  • Extensive knowledge of USP, ICH, FDA, and DEA regulations.
  • Extensive 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.
  • Minimum of six (6) years of experience in a pharmaceutical environment with a minimum four (4) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).

Job Tags

Contract work,

Similar Jobs

Beijing Lan Xiaoyu Information Consulting Center

actor/model Job at Beijing Lan Xiaoyu Information Consulting Center

Job Responsibilities:1. Perform in short play performances as required;2. Complete assigned acting tasks with a certain level of expressiveness;

Animal Magnetism

Dog Walker and Pet Sitters Job at Animal Magnetism

 ...Dog Walker & Pet Sitter $20/hr Starting, Flexible, Fun, and Active! Love dogs?...  ...team. In this role, youll spend your days walking dogs (often in small, friendly pack walks...  ...Requirements ~18 years or older ~ Hands-on experience with dogs (walking, shelter, vet, or... 

CyberCoders

Heavy Equipment Mechanic Job at CyberCoders

 ...equipment and systems. This role involves conducting regular maintenance, troubleshooting issues, and adhering to safety procedures on offshore rigs. Key Responsibilities Conduct regular maintenance and inspections of rig equipment and systems Troubleshoot... 

Vitana Pediatric & Orthodontic Partners

Digital Marketing Manager Job at Vitana Pediatric & Orthodontic Partners

 ...Were hiring a versatile Digital Marketing Manager to lead our in-house SEO, local search, and paid search advertising efforts . Youll manage all aspects of digital visibility across multiple pediatric dental and orthodontic practice brandsdeveloping and optimizing... 

GP Strategies Government Solutions

Aircraft Electrical Instructor/Trainer Job at GP Strategies Government Solutions

 ...sustainable growth and mission success. GP Strategies Government Solutions, Inc. has a position open for an Aircraft Electrical Instructor with aircraft electrical systems experience to support a large aerospace client in San Antonio, TX. This is a full-time,...