Job Title: Quality Data Reviewer

Work Location: Wake County, North Carolina

Summary:

Responsible for conducting GMP/GDP data review of laboratory analyses and associated write-up documentation (including but not limited to wet chemistry and HPLC analysis). The Quality Data Reviewer will assure the analysts’ adherence to test methods, SOPs, etc. when reviewing data, and that data integrity was maintained throughout the testing process. The Quality Data Reviewer will also author laboratory investigation reports (i.e. invalidation and OOS reports).

Responsibilities:

• Audit and approve laboratory data and reports (including wet chemistry and HPLC data)
• Ensure sample data is correctly input into LIMS as required
• Author lab investigations in relation to invalid or out-of-specification results (with input from analysts)
• Review equipment logbooks periodically to ensure continued validated state of instrumentation
• Assist in sample tracking and update sample database when samples are released from the lab
• Ensures laboratory analyses are performed in accordance with GMP/GDP practices
• Assures data integrity and ALCOA standards are applied to all laboratory data
• Responsible for authoring laboratory investigations (invalidations, out-of-specifications) with input from analysts
• Assist analysts in determining a root cause for aberrant results
• Responsible for making sure samples released from the lab are tracked in the lab database
• Responsible for reviewing equipment logbooks
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.
• Report all safety and/or environmental incidents to management immediately.
• Support various information requests from other departments.
• Assist Lab Supervisors/Manager with tracking investigation and testing cycle times.
• Other duties as assigned with or without accommodation.

Qualifications:

• BS/BA degree in Life Sciences
• Seven to ten years experience in a pharmaceutical setting; previous investigation writing and auditing experience preferred
• Good documentation skills with eye for details
• Ability to work in a fast paced environment
• Meets Baseline Skills requirements
• Familiarity and skilled competency with computers, lab equipment software (Empower 3, Total Chrome, etc) and MS Office software environment

Organizational Relationships/Scope:

The position routinely interfaces with various personnel from each of the operating departments and product safety and regulatory affairs groups. Frequent contact with external suppliers.

Working Conditions:

Desk with computer; Chemistry lab; Production facility

Published Category: Quality & Validation