Quality Assurance Coordinator - Scientific Data

Revance • Johnson City, TN

6d • Onsite

About The Position

The QA Coordinator – Scientific Data role supports site Quality Assurance through review and approval of Quality Control laboratory data and investigations in compliance with FDA 21 CFR 210/211/11 and ICH Q1-10. This role performs an in-depth review of the finished laboratory product and raw material analytical data, final QA disposition of raw materials and finished products, and review and approval of lab-related investigations in close collaboration with other site Quality personnel.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related technical field required.
• Minimum 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.

Nice To Haves

• Experience with laboratory investigations for deviations, OOS/OOT results, and nonconformances preferred.
• In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q1–Q10, and relevant USP chapters.
• Proficiency in review of laboratory analytical data.
• Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance.
• Familiarity with data integrity requirements and ALCOA+ compliance.

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 SOPs related 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

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Paid Time Off, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level