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Contract QA Data Reviewer
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 Contract Data Reviewer to join their New Brunswick, New Jersey 08901 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.
Full-time Onsite
Contract
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
Qualifications:
About ProStaff
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.
Our Values
• Integrity
• Commitment
• Quality
• Diversity
Benefits for eligible employees
• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
#ps
Full-time Onsite
Contract
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.
Qualifications:
- Minimum of a Bachelors.
- 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).
- 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.
- 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).
About ProStaff
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.
Our Values
• Integrity
• Commitment
• Quality
• Diversity
Benefits for eligible employees
• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
#ps