Quality Control Chemist II

Revance•Johnson City, TN

6d•Onsite

About The Position

The Quality Control Chemist II is an experienced analytical scientist who independently performs advanced qualitative and quantitative testing to support raw material qualification, in-process monitoring, stability studies, bulk intermediates, and finished product release. The role requires strong technical competency in chromatography, instrumental analysis, troubleshooting, cGMP compliance, and data integrity. The Chemist performs complex testing with minimal supervision, leads technical portions of investigations, supports method verification and validation, resolves analytical abnormalities, and contributes to continuous improvement in the QC laboratory. The role also serves as a technical resource for team members and collaborates with Manufacturing, QA, Supply Chain, R&D, and Validation. The position is onsite in Johnson City, Tennessee, and reports to the Supervisor, Quality Control.

Requirements

Bachelor’s degree in Chemistry or a related scientific discipline, with 5–7 years of experience in a GMP/GLP laboratory environment; industry, academic, or internship experience is acceptable for Chemist II.
Alternatively, a master’s degree in Chemistry or a related scientific discipline with 2–4 years of experience.
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, including ICH, CFR, and FDA guidance.
Effective written and verbal communication skills.
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Nice To Haves

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

Responsibilities

Independently perform routine and non-routine testing of raw materials, in-process materials, intermediates, finished goods, and stability samples using validated methods in accordance with cGMP and compendial requirements.
Prepare reagents, standards, and sample solutions precisely, documenting and tracing materials used in analytical activities.
Operate, maintain, and troubleshoot laboratory instruments and analytical systems, including HPLC, GC, UV-Vis, FTIR, Karl Fischer, and viscometers.
Execute environmental monitoring activities where applicable, interpret data trends, and escalate deviations according to SOPs.
Document analytical data in laboratory notebooks and electronic systems such as LIMS, following ALCOA+ data integrity principles and cGMP/GLP guidelines.
Assist with OOS, OOT, and atypical-result investigations, including root cause analysis and corrective action implementation.
Participate in qualification, verification, and validation of analytical methods, equipment, and laboratory systems under guidance from senior QC or Validation personnel.
Support continuous improvement initiatives such as 5S, workflow optimization, and CAPA implementation.
Provide informal technical coaching to QC team members in method execution, data review, and troubleshooting.
Follow site safety, EHS, and hazardous-material handling requirements, and promptly report safety concerns and near misses.
Maintain laboratory cleanliness, audit readiness, and adherence to cGMP expectations.
Collaborate 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.