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Quality Control/ Quality Assurance Data Reviewer
2 months ago
Our pharmaceutical client, is looking for a Data Reviewer to join their team If you are someone who wants to be apart of a growing and technical environvment and gain further exposure to Quality systems, this might be the role for you
This position requires experience with hands on testing in a Quality Control laboratory operating within a cGMP environment. This review will also extend to Quality Systems in the laboratory such as Reference Standards, Instrumentation Logbooks, LC/GC Column Inventory, etc.
Key Responsibilities:
- Review and approve hard copy notebook pages for the Laboratory Analysts in the QC and AR&D laboratory team.
- Review and sign-off of electronic data files within the Empower data acquisition software system.
- Conduct a review of the Reference Standard logs for completeness and remove any expired standard materials.
- Conduct a periodic review of instrument logbooks and work with the team to correct any omissions.
- Support the laboratory analysts to ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs).
- Conduct a review of the column inventory logs for completeness and remove any damaged or unusable columns.
Minimum Qualifications:
- Bachelor’s degree in chemistry
- 2+ years of experience in the pharmaceutical industry.
- Hands-on experience with HPLC, GC, Dissolution, and use of Empower software.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork skills.
- Attention to detail and commitment to maintaining data integrity.