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Physician / New Jersey / Locum or Permanent / QC Data Reviewer Job

Location
Somerset, New Jersey
Job Type
Permanent
Posted
13 Jul 2022

A pharmaceutical company in New Jersey is looking to fill an immediate need with the addition of a new QC Data Reviewer. In this role, the QC Data Reviewer will be responsible ensuring all QC Laboratory testing data are of the highest quality for audit trails and paper records purposes.

Responsibilities:

The QC Data Reviewer will be responsible for:
  • Reviewing QC Laboratory data for conformance to procedures and specifications, and proper documentation in accordance with the company's SOPs and cGMPs
  • Reviewing equipment audit trails and logbooks to for alignment and immediately elevating & helping investigate any discrepancies
  • Reviewing all electronic data system access logs and control lists to ensure they are appropriate and accurate
  • Discussing questions or potential discrepancies in audit trails with area supervisors, elevate and investigate, if necessary to determine the impact on the data or data system
  • Verifying that appropriate data backups are complete on each data system
  • Ensuring the integrity of all data systems used in the manufacture or testing of drug products
  • Reviewing and (in some instances) performing routine data backups of data systems
  • Periodically auditing system audit trails against paper records, usage logs etc.
  • Reviewing system policies and user access controls against paper records
  • Interacting closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements
  • Assisting in perform Quality Assurance audits of laboratory and manufacturing areas to ensure cGMP compliance
  • Assisting in the investigation and review of deviation reports and reports to assure complete compliant source data
  • Assisting in training and mentoring a variety of personnel on the use of electronic data systems
  • Performing other duties, as needed

Qualifications:

  • 2+ years of experience in a Quality role within the Biotechnology, Life Sciences, and/or Pharmaceutical industry
  • Bachelor's Degree in a Life Sciences-related field (Biochemistry, Chemistry, and/or a closely related field)
  • Complete knowledge of current Good Manufacturing Practices, United States Pharmacopea, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance
  • Solid analytical and research skills
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized

Desired Skills:

  • Prior experience with Pharmaceutical Manufacturing
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Details

  • Job Reference: 657097658-2
  • Date Posted: 13 July 2022
  • Recruiter: The Execu Search Group.
  • Location: Somerset, New Jersey
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent