QC Lab Lead: GMP, Method Dev & Compliance

The Goodkind Co, a Certified B-Corp; Round Rock (TX); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

The Goodkind Co. in Texas seeks a Senior Chemist / Laboratory Supervisor to lead the QC Laboratory in a regulated manufacturing setting.

You will oversee daily laboratory operations, drive GMP compliance, data integrity, and scalable QC processes to support OTC product manufacturing. As the technical lead, you will guide method development, validation, investigations, and cross‑functional collaboration with QA, Manufacturing, R&D, and Operations.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or related discipline.
• 5+ years of laboratory experience in a regulated manufacturing environment.
• Strong GMP knowledge and laboratory compliance expectations.
• Experience interpreting FDA OTC Monographs and USP methods.
• Experience with method development, qualification, and validation.
• Experience leading investigations and corrective actions.
• Experience supervising laboratory personnel.

Responsabilités

• Lead daily QC laboratory operations and supervise personnel.
• Establish GMP practices, controls, and documentation standards.
• Develop, qualify, validate, and improve analytical methods.
• Lead investigations for OOS, deviations, and nonconformances.
• Review data and documentation for accuracy and compliance.
• Ensure calibration and qualification of equipment.
• Support data integrity practices.
• Coordinate scheduling and resource planning.
• Partner with QA, Manufacturing, R&D, and Operations to improve product quality.
• Support audits and regulatory inspections.
• Identify continuous improvement opportunities for efficiency and compliance.
• Train and mentor laboratory staff in GMP.

Connaissances

GMP Compliance

Laboratory Leadership

Method Development

Data Integrity

Root Cause Analysis

Cross-functional Collaboration

Documentation & Writing

Instrument Calibration

Formation

Bachelor's degree in Chemistry or related

Outils

LIMS

ERP Systems

Analytical Instruments

Description du poste

The Goodkind Co. in Texas seeks a Senior Chemist / Laboratory Supervisor to lead the QC Laboratory in a regulated manufacturing setting.

You will oversee daily laboratory operations, drive GMP compliance, data integrity, and scalable QC processes to support OTC product manufacturing. As the technical lead, you will guide method development, validation, investigations, and cross‑functional collaboration with QA, Manufacturing, R&D, and Operations.