Quality Control Chemist II

Job Summary:

The Quality Control Chemist II is an experienced analytical scientist responsible for independently performing advanced qualitative and quantitative analyses to support raw material qualification, in‑process monitoring, stability studies, bulk intermediates, and finished product release. The QC Chemist II demonstrates strong technical competency in chromatography, instrumental analysis, troubleshooting, cGMP compliance, and data integrity.

This role performs complex testing with minimal supervision, leads technical portions of investigations, supports method verification/validation, identifies and resolves analytical abnormalities, and helps drive continuous improvement within the QC laboratory. The QC Chemist II is expected to influence team performance, model high standards of documentation and compliance, and collaborate effectively with Manufacturing, QA, Supply Chain, R&D, and Validation.

Reporting to: Supervisor, Quality Control
Location: Johnson City, TN - onsite

Responsibilities/Essential Duties:

• Independently perform routine and non‑routine testing (raw materials, in‑process, intermediates, finished goods, and stability) using validated methods in accordance with cGMP and compendial requirements (USP, EP).
• Prepare reagents, standards, and sample solutions with precision, ensuring proper documentation and traceability of materials used in analytical activities.
• Operate, maintain, and troubleshoot laboratory instrumentation including but not limited to HPLC, GC, UV-Vis, FTIR, Karl Fischer, viscometers, and other analytical systems with no supervision.
• Execute environmental monitoring activities (where applicable), interpret data trends, and escalate deviations per SOP.
• Accurately document all analytical data in laboratory notebooks and electronic systems (e.g., LIMS) in accordance with ALCOA+ data integrity principles and cGMP/GLP guidelines.
• Assist in laboratory investigations including OOS, OOT, and atypical results, supporting root cause analysis and corrective action implementation.
• Participate in the qualification, verification, and validation of analytical methods, equipment, and laboratory systems under the guidance of senior QC or Validation personnel.
• Support continuous improvement initiatives, including 5S, workflow optimization, and implementation of corrective/preventive actions (CAPA).
• Serve as a technical resource for QC team members, providing informal coaching in method execution, data review, and troubleshooting.
• Comply with all site-wide safety, EHS, and hazardous material handling requirements; promptly report safety concerns and near misses.
• Maintain laboratory cleanliness, readiness for internal/external audits, and adherence to cGMP expectations.
• Collaborate cross-functionally with QA, Manufacturing, Supply Chain, R&D, and Validation to resolve analytical issues and support timely batch disposition.
• Perform additional duties, projects, or training assignments as delegated by QC leadership.

Required Qualifications:

• Bachelor’s degree (B.S./B.A.) in Chemistry, or related scientific discipline.
• 5-7 years of experience in a GMP/GLP laboratory environment (industry, academic, or internship acceptable for Chemist II).
• OR Master’s degree in chemistry, or related scientific discipline with 2-4 years of experience.
• Demonstrated ability to follow written procedures accurately and maintain high-quality documentation.
• Strong attention to detail, analytical thinking, and problem-solving skills.
• Strong understanding of advanced analytical chemistry principles and regulatory requirements (ICH, CFR, FDA guidance).
• Effective written and verbal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

Preferred Qualifications:

• Experience working in a regulated pharmaceutical, OTC drug, cosmetic, or medical device manufacturing environment.
• Familiarity with LIMS or other laboratory information management systems.
• Capable of training peers in analytical techniques or instrumentation.
• Working knowledge of compendial methods (USP, EP, JP) and pharmacopeial requirements.
• Prior support of method validation/verification, analytical troubleshooting, and instrument qualification.
• Experience with data integrity, FDA 21 CFR Part 211, and ICH Q2(R2) expectations.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. 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. …