Quality Assurance 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

Job Summary

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.

Reporting to: Quality Assurance Supervisor

Location: Johnson City, TN Onsite

Schedule: Mon-Fri, 8:00am - 5:00pm

Responsibilities/Essential Duties

• 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

Basic Qualifications

• 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.

Company Summary

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.

What Revance invests in you:

• 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!

Work Environment & Physical Requirements

This position requires extended periods of standing and walking on a manufacturing floor environment. Protective equipment (safety glasses, hearing protection, gowning) must be worn as required. The role 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.

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.