Quality Assurance Coordinator - Scientific Data

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. The Company drives innovation beyond convention to offer treatment options for individuals across generations, with an unwavering commitment to providers, patients, and consumers.

About the role

This position 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. The role performs an in-depth review of 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.

Reporting to the Quality Assurance Supervisor. Location: Johnson City, TN.

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.
• Assists 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.

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.
• Experience with laboratory investigations for deviations, OOS/OOT results, and nonconformances preferred.

Preferred Qualifications

• 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.

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 more.

Schedule

Onsite, Monday through Friday, 8:00 AM – 5:00 PM.

Work Environment & Physical Requirements

• Extended periods of standing and walking on a manufacturing floor environment.
• Protective equipment (safety glasses, hearing protection, gowning) must be worn as required.
• Operates in a temperature-controlled pharmaceutical manufacturing facility.
• Occasional lifting of up to 30 lbs may be required.
• Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis.