QA Data Integrity Coordinator, Scientific Data

Revance; Johnson City (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

Revance is hiring a QA Coordinator - Scientific Data in Johnson City, TN to support site Quality Assurance through review and approval of laboratory data and investigations in compliance with FDA 21 CFR 210/211/11 and ICH Q1-10. This role collaborates with QC Lab personnel to ensure data integrity and timely disposition of materials and products.

The position reports to the Quality Assurance Supervisor and requires a Bachelor's degree in Life Sciences or related field, plus 1–4 years of QC

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related technical field.
• 1–4 years of Quality Control experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment.
• Demonstrated expertise in review of analytical laboratory data for finished products and raw materials.
• Experience with laboratory investigations for deviations, OOS/OOT results, and nonconformances preferred.

Responsibilities

• Performs QA review of lab-related notices of potential events, investigations for deviations, OOS/OOT results, and nonconformances to ensure compliant cGMP documentation, data integrity and timely completion in collaboration with QC Lab personnel.
• Assist in driving timeliness of potential events and laboratory investigations from Draft phase to Completion phase.
• Analyzes and trends investigation data to identify systemic issues, recommends process or procedural improvements including CAPAs, and reports lab-related investigation metrics to Quality leadership as requested.
• Performs a thorough review of all laboratory analytical data for both raw materials and finished product testing, ensuring data meets ALCOA+ data-integrity.
• Approves raw material item specifications and finished product COAs, changing disposition as applicable through electronic inventory system prior to raw material use and/or final finished product release.
• Supports the workflow and timeliness of releasing raw materials for production use as needed.
• Revises QA SOPsrelated to analytical data review and material deposition as needed.
• Supports revision of QA SOPs, product specifications, work instructions and/or other GMP documents pertaining to QA oversight of analytical data and final batch disposition as needed.

Education

Bachelor's degree in Life Sciences, Engineering, or related technical field

Tools

MasterControl

Veeva

ETQ Reliance

Job description

Revance is hiring a QA Coordinator - Scientific Data in Johnson City, TN to support site Quality Assurance through review and approval of laboratory data and investigations in compliance with FDA 21 CFR 210/211/11 and ICH Q1-10. This role collaborates with QC Lab personnel to ensure data integrity and timely disposition of materials and products.

The position reports to the Quality Assurance Supervisor and requires a Bachelor's degree in Life Sciences or related field, plus 1–4 years of QC