Microchem Laboratory · 3 months ago
Quality Assurance/Quality Control Team Leader - Laboratory setting
Richardson, TX
Contract
Onsite
Senior Level
5+ years expMicrochem Laboratory is seeking an experienced Laboratory Quality Manager to lead quality operations within a GMP-regulated contract testing environment. The role involves overseeing quality systems, ensuring compliance with regulatory requirements, and supporting laboratory teams in delivering accurate product quality testing results while driving continuous improvement and maintaining audit readiness.
CosmeticsHealth CareMedicalTest and Measurement
Responsibilities
Oversee the development, implementation, and maintenance of laboratory quality systems in compliance with GMP and applicable regulatory guidelines (FDA, ICH, ISO)
Manage and review product quality testing activities to ensure accuracy, reliability, and regulatory compliance
Lead investigations of deviations, out-of-specification (OOS) results, and laboratory incidents, ensuring thorough root cause analysis and CAPA implementation
Approve and maintain SOPs, quality policies, and documentation to ensure consistency and compliance
Coordinate internal audits, host external regulatory inspections, and respond to audit findings with effective corrective actions
Ensure proper training of laboratory staff on GMP requirements, documentation practices, and quality procedures
Oversee the review and approval of laboratory data, reports, and records for accuracy and compliance with data integrity principles (ALCOA)
Collaborate with operations, validation, and supply chain teams to ensure quality integration across workflows
Monitor key performance indicators (KPIs) and quality metrics to drive continuous improvement initiatives
Stay current with evolving regulatory requirements and industry best practices, recommending updates to procedures and systems as needed
Qualification
Required
Bachelor's degree in Microbiology, Chemistry, Biology, or related scientific field (advanced degree preferred)
Minimum of 5–7 years' experience in a GMP-regulated laboratory environment, with at least 3 years in a quality management or supervisory role
Strong knowledge of GMP, GLP, and applicable FDA/ICH guidelines
Proven experience in product quality testing, data review, and quality oversight
Demonstrated ability to manage audits, regulatory inspections, and CAPA processes
Excellent leadership, organizational, and communication skills
Proficiency with laboratory information systems (LIMS) and electronic documentation systems preferred
Supreme attention to detail
Ability to be a self-starter and critical thinker while working cooperatively with others in a small-company environment
Preferred
Bachelor's Degree with a Chemistry focus
Prior work experience in a laboratory setting
Deep technical knowledge of microbiology theory and practice
Technical knowledge of chemistry testing
Experience in the safe handling of pathogenic microorganisms
Proficiency in Microsoft Office
Ability to travel as needed to HQ for training/events
Interact with and provide detailed information to collaborating personnel
Maintain a safe, fast-paced, and positive laboratory environment
Company
Microchem Laboratory
Microchem Laboratory is an FDA and EPA GLP-compliant contract testing facility.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase