Full-Time and Part-time Opportunities Available for Quality Data Review (On-Site)
Position Overview: The Quality Data Reviewer is essential to maintaining compliance with current Good Manufacturing Practices (cGMP) standards and regulatory requirements within the laboratory environment. This role is pivotal in supporting the integrity of testing processes, ensuring data accuracy, and upholding overall quality assurance in the contract laboratory environment.
Key Responsibilities: Key responsibilities include reviewing all analytical data generated by the laboratory to ensure its accuracy and reliability, as well as ensuring that sample testing procedures align with client requests and meet regulatory standards. Additionally, the role involves drafting Certificates of Analysis and Reports of Analysis, utilizing EQMS and other quality management software to maintain the integrity and compliance of quality-related data.
Desired Skill Set:
Knowledge of cGMP requirements and other regulatory standards (e.g., FDA, ISO) relevant to contract testing laboratories.
Strong analytical skills with the capability to identify discrepancies and inconsistencies in data.
Ability to critically evaluate test results and ensure compliance with specifications.
Ability to review and understand analytical methods and laboratory protocols.
Able to write and review reports with clarity and brevity.
Thorough knowledge of and competence in quality processes, including but not limited to deviations, OOS investigations, and CAPA management.
Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) for data management and reporting.
Education and Experience: Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry); 5+ years of experience in QA/QC within the pharmaceutical industry.
Work hours and specific times are to be determined and can be flexible between 8 AM and 6 PM.
To Apply, please send a cover letter and resume to [email protected]
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