Senior Chemist / Laboratory Supervisor
On-siteRound Rock, Texas, United States
Job Summary
Lead daily QC laboratory operations and supervise laboratory personnel while establishing and strengthening GMP practices, controls, and documentation standards. Develop, qualify, validate, and improve analytical test methods and procedures; lead investigations related to OOS, atypical results, deviations, and nonconformances. Review laboratory data and documentation for accuracy and compliance; ensure proper calibration, maintenance, and qualification of equipment. Support implementation of data integrity practices and develop laboratory SOPs, specifications, and test methods. Coordinate scheduling, testing priorities, and resource planning; partner cross-functionally with QA, Manufacturing, R&D, and Operations. Train and mentor staff on GMP requirements and techniques; support audit readiness and continuous improvement initiatives.
Required Qualifications
- Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline
- 5+ years of laboratory experience in a regulated manufacturing environment
- Strong working knowledge of GMP requirements and laboratory compliance expectations
- Experience interpreting FDA OTC Monographs and USP test methods
- Experience with analytical method development, qualification, and validation
- Experience leading laboratory investigations, root cause analysis, and corrective actions
- Experience supervising or leading laboratory personnel
- Strong understanding of laboratory instrumentation, calibration, and data integrity principles
- Strong technical writing, analytical, and organizational skills
- Ability to manage multiple priorities in a fast-paced environment
Desired Qualifications
- Experience in OTC, pharmaceutical, cosmetic, or personal care manufacturing
- Experience supporting FDA inspections and regulatory audits
- Familiarity with ISO standards and laboratory quality systems
- Experience with stability programs and specification management
- Experience with ERP systems, LIMS, or electronic quality systems
- Knowledge of risk assessment and continuous improvement methodologies
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