QA Data Reviewer I - 14205458

Job Description

Are 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:

• 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.

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Company Description

Prostaff Solutions is committed to all aspects of staffing services

We offer comprehensive best-practices for our clients and employees.

Our Vision:

ProStaff Solutions strives to be the premier employment solutions provider to every community we serve.

Our Mission:

Our mission is to bring the right people to the right job every time. Accomplishing this, we better people's lives and increase our customers and employees success.

Our Values :

Our Pledge of Integrity

Our name is the most important thing we own. To us, it is more than an identity. It is also how we act. It is both the foundation and the heart of our business.

Because our success depends on our personal integrity and honesty, we work hard. We also reward hard work. We believe great things happen when we listen to each other, and that is why our doors are always open. We also strive to strengthen our communities by example in leadership, and by donations of time and resources.

Prostaff Solutions is committed to all aspects of staffing services We offer comprehensive best-practices for our clients and employees. Our Vision: ProStaff Solutions strives to be the premier employment solutions provider to every community we serve. Our Mission: Our mission is to bring the right people to the right job every time. Accomplishing this, we better people's lives and increase our customers and employees success. Our Values : Our Pledge of Integrity Our name is the most important thing we own. To us, it is more than an identity. It is also how we act. It is both the foundation and the heart of our business. Because our success depends on our personal integrity and honesty, we work hard. We also reward hard work. We believe great things happen when we listen to each other, and that is why our doors are always open. We also strive to strengthen our communities by example in leadership, and by donations of time and resources.