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QC Technician - Stability
Johnson City, TN · On-site · QC Lab
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About the role
ExcelComplianceManufacturingQuality Assurance
Job Summary:
The Stability Technician is an entry-level technical role responsible for supporting the stability program and daily stability activities in a regulated manufacturing environment. This position focuses on executing established procedures, accurate documentation, and routine stability tasks, including sample storage, pulls, and data entry that support product quality, shelf-life determination and regulatory compliance at Crown Laboratories.
The Stability Technician works under direct supervision and follows approved SOPs, stability protocols, cGMP requirements, and quality system expectations to ensure compliance with internal and external regulatory standards, including ICH Q1A(R2) guidance. This role collaborates with Manufacturing, Quality Assurance, Regulatory, and other support functions to maintain the integrity of stability studies and a state of audit readiness.
Reporting to: Quality Control Supervisor
Location: Johnson City, TN Plant
Schedule: 8:00am - 4:30pm
Responsibilities/Essential Duties:
- - Perform routine stability program tasks in accordance with approved SOPs, stability protocols, cGMP requirements, and company quality policies.
- Receive, log, and place stability samples into designated ICH-controlled environmental chambers (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH) per protocol.
- Pull stability samples at scheduled time points, maintain pull schedules, and deliver samples to testing laboratories.
- Monitor and record stability chamber temperature and humidity; report excursions and assist with excursion investigations and impact assessments.
- Maintain accurate inventory and reconciliation of stability samples, including retained, discarded, and returned materials.
- Review stability data and documentation for completeness, accuracy, and compliance, escalating discrepancies, OOS, OOT, and atypical results per procedure.
- Support deviation, nonconformance, and CAPA processes related to stability by gathering data, documenting information, and tracking actions as assigned.
- Assist with preparation of stability protocols, summaries, and reports, including data entry and trending in LIMS or other electronic systems.
- Maintain accurate records in paper-based and electronic systems in accordance with ALCOA+ data integrity principles.
- Support chamber maintenance, calibration, qualification, and mapping activities and coordinate with Facilities and Metrology as needed.
- Participate in internal audits, inspections, and audit readiness activities by assisting with document retrieval and stability area preparation.
- Communicate quality issues or potential compliance concerns promptly to QC leadership.
- Comply with all site safety, EHS, and hazardous material handling requirements, and maintain a clean, organized work environment that supports cGMP compliance.
- Perform additional duties, projects, or training assignments as required by QC leadership.
Basic Qualifications:
- High School diploma or GED required; Associate’s or Bachelor’s degree in a scientific or related discipline preferred.
- 0–2 years of experience in a GMP-regulated environment (stability, laboratory, manufacturing, or quality systems preferred).
- Ability to follow written procedures and stability protocols accurately and consistently.
- Strong attention to detail, organization, and commitment to documentation accuracy, including adherence to pull schedules and time points.
- Basic computer skills, including proficiency with Microsoft Word and Excel.
- Effective verbal and written communication skills.
- Ability to work effectively in a team environment.
Preferred Qualifications:
- Experience working in a regulated pharmaceutical, OTC drug, cosmetic, or medical device manufacturing environment.
- Hands-on experience with stability studies, environmental chambers, and sample pull and inventory management.
- Familiarity with LIMS or other laboratory information management systems and environmental monitoring systems.
- Working knowledge of compendial methods (USP, EP, JP) and pharmacopeial requirements.
- Understanding of ICH Q1A(R2), FDA 21 CFR Part 211, and data integrity expectations, including OOS/OOT handling.
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.