QC Laboratory Lead - GMP, Method Development and Compliance

Goodkind Co; Round Rock (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Goodkind Co. is seeking a Senior Chemist / Laboratory Supervisor to lead the Quality Control Laboratory in a regulated manufacturing setting.

You will oversee day-to-day QC operations, strengthen GMP practices, and drive improvements in analytical methods and data integrity. You will serve as technical lead for investigations, method development, validation, and implementation of robust laboratory controls while mentoring staff and ensuring compliance with internal quality standards and OTC

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

Responsibilities

• Lead daily QC laboratory operations and supervise laboratory personnel.
• Establish and strengthen GMP laboratory practices, controls, and documentation standards.
• Develop, qualify, validate, and improve analytical test methods and laboratory procedures.
• Lead laboratory investigations related to OOS, atypical results, deviations, and nonconformances.
• Review laboratory data, test results, and analytical documentation for accuracy, reliability, and compliance.
• Ensure proper calibration, maintenance, and qualification of laboratory equipment and instruments.
• Support implementation and oversight of laboratory data integrity practices.
• Develop and improve laboratory SOPs, specifications, test methods, and related documentation.
• Coordinate laboratory scheduling, testing priorities, and resource planning.
• Partner cross-functionally with QA, Manufacturing, R&D, and Operations to support product quality and process improvements.
• Support validation activities, including method validation, equipment qualification, and stability-related activities as applicable.
• Train and mentor laboratory staff on GMP requirements, laboratory techniques, and compliance expectations.
• Support audit readiness activities, regulatory inspections, and internal audits.
• Identify and implement continuous improvement initiatives to improve laboratory efficiency, compliance, and technical capability.

Skills

GMP operations

Analytical methods

Lab investigations

Leadership

Data integrity

Equipment calibration

Cross-functional

Documentation

Problem solving

Education

Bachelor's in Chemistry

Job description

Goodkind Co. is seeking a Senior Chemist / Laboratory Supervisor to lead the Quality Control Laboratory in a regulated manufacturing setting.

You will oversee day-to-day QC operations, strengthen GMP practices, and drive improvements in analytical methods and data integrity. You will serve as technical lead for investigations, method development, validation, and implementation of robust laboratory controls while mentoring staff and ensuring compliance with internal quality standards and OTC