Quality Assurance Specialist

Revance Therapeutics Inc

Nashville, TN

JOB DETAILS
SKILLS
American National Standards Institute (ANSI), American Society for Quality (ASQ), Biotech and Pharmaceutical, Check Processing, Code of Federal Regulations, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Document Management, Documentation, Drug Manufacturing, High School Diploma, ICH Regulations, Maintain Compliance, Manufacturing, Manufacturing Operations, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Patient Safety, Problem Solving Skills, Procedure Development, Procedure Implementation, Process Quality, Quality Assurance, Quality Management, Quality Metrics, Reconciliation, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Root Cause Analysis, Safety Compliance, Standard Operating Procedures (SOP), Support Documentation, Team Player, Time Management
LOCATION
Nashville, TN
POSTED
3 days ago

Job Summary:

The QA Specialist I - Manufacturing Quality Assurance (MQA) is responsible for providing on-the-floor support to manufacturing, filling, and packaging operations to ensure compliance with cGMP, SOPs, and applicable regulatory requirements. This entry-level role focuses on performing in-process quality checks, assisting in batch record review, and supporting deviation documentation under the guidance of senior QA staff. The Specialist I helps maintain product quality, compliance, and patient safety by executing defined QA responsibilities and building technical expertise in pharmaceutical quality systems.

Reporting to: Quality Assurance Supervisor

Location: Johnson City, TN Manufacturing Plant

Schedule: Mon-Fri 7:00AM - 4:30PM

Responsibilities/Essential Duties:

  • Perform quality checks during manufacturing, filling, and packaging activities, including weight checks, seal integrity checks, line clearance verification, cleaning verification, and label reconciliation.
  • Document inspection activities in accordance with Good Documentation Practices (GDP) and company procedures.
  • Assist in the review of executed batch records for completeness and accuracy.
  • Support QA oversight of equipment set-up and clearance activities under supervision.
  • Participate in deviation documentation and investigations under the guidance of2026-03-04 senior QA staff.
  • Aid in the preparation and revision of SOPs and controlled documents.
  • Perform other quality-related tasks as assigned by QA Management.
  • Follow established procedures to ensure compliance with 21 CFR Parts 210/211, ICH guidelines, and company Quality Management System (QMS) requirements.
  • Uphold GDP and data integrity standards during all inspection and documentation activities.
  • Escalate potential compliance issues to senior QA staff in a timely manner.
  • Support regulatory inspections and customer audits by providing accurate information as requested.
  • Demonstrate proficiency in inspection methodologies, measurement tools, and acceptance sampling standards (e.g., ANSI/ASQ Z1.4).
  • Gain working knowledge of cGMP manufacturing and packaging operations.
  • Learn and apply basic root cause analysis and problem-solving tools under the direction of senior QA personnel.
  • Build proficiency in quality oversight practices and regulatory expectations through on-the-job training.
  • Collaborate with operations staff to reinforce compliance and quality standards on the production floor.
  • Participate in quality training sessions to support professional growth and readiness for Level II responsibilities.

Basic Qualifications:

  • High School Diploma or equivalent required; Associate degree in a scientific or technical discipline preferred.
  • Minimum 0-2 years of experience in Quality Assurance, Manufacturing, or a regulated industry (pharmaceutical/biotechnology preferred),
  • Basic understanding of cGMP and regulatory requirements for pharmaceutical production.
  • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
  • Strong attention to detail, communication, and organizational skills.
  • Ability to follow procedures, take direction, and work collaboratively in a team environment

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.

About the Company

R

Revance Therapeutics Inc