Accentuate Staffing is currently recruiting for a  QC Specialist (Data Reviewer) to join an established company in the RTP area.

Responsibilities: 

• Quality Control (QC) technical, scientific and compliance review of data generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP)
• Coordinate work prioritization with the QC Manager, Bioanalytical Project Managers and Quality Assurance to ensure that study timelines are met
• Identify deviations, OOS and OOT associated with Bioanalytical Operations data
• Issue QC review reports and work closely with the scientific staff to ensure compliance with appropriate regulations
• Function as a Subject Matter Expert in regard to QC processes
• May serve as a backup trainer on the QC review process
• May act as a mentor to junior-level QC data reviewers
• May review protocols, testing plans, reports and other study-related documentation
• Assist in collecting metrics data used to monitor the QC processes and may identify and assist with implementing QC process improvements
• Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance
• Write and/or review QCT SOPs

Requirements: 

• Bachelor’s degree in biological science or related field with > 8 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization
• At least two years of experience performing data review in a GxP environment
• Extensive knowledge of GxP regulations
• Broad experience with large molecule bioanalytical methods such as immunoassays and cell-based assays
• Ability to review a wide range of bioanalytical data in an effective and efficient manner
• Demonstrated proficiency in the use of MS Excel and Word
• Demonstrated proficiency in the use of LIMS and Quality Management software packages