QA Specialist - Manufacturing Quality Assurance I

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
• Hours: Variable

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 of senior QA staff.
• Aid in the preparation and revision of SOPs and controlled documents.
• Perform other quality-related tasks as assigned by QA Management.

Compliance & Regulatory

• 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.

Technical Expertise & Development

• 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.

Physical & Work Environment Requirements

• Ability to work in controlled manufacturing and packaging environments, including gowning/PPE requirements.\
• Ability to stand, walk, and perform shop-floor oversight for extended periods.
• May require occasional lifting of 5-25 lbs.
• Flexibility to support off-shift or weekend activities as required by production

Required 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:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus
• Paid time off, holidays, and floating holidays that can be used for whatever you choose
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more

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.