Microchem Laboratory · 2 hours ago
Laboratory Quality Team Lead (GMP)
Richardson, TX
Full-time
Onsite
Mid, Senior Level
3+ years expMicrochem Laboratory is an independent contract testing facility specializing in personal care product testing and compliance with FDA and EPA standards. They are seeking a hands-on Quality Team Lead to oversee quality operations in a GMP-regulated environment, ensuring compliance and continuous improvement in laboratory testing processes.
CosmeticsHealth CareMedicalTest and Measurement
Responsibilities
Provide strategic and operational leadership for laboratory quality systems in compliance with GMP, FDA, ICH, and ISO requirements
Lead and mentor the Quality Team, fostering a culture of quality ownership, accountability, and continuous improvement
Oversee and review product quality testing activities to ensure data integrity, accuracy, and regulatory compliance
Lead investigations for deviations, OOS/OOT results, and laboratory incidents, ensuring effective root cause analysis and timely CAPA implementation
Own the SOP lifecycle, including review, approval, and continuous improvement of quality documentation and policies
Plan and conduct internal audits, host external regulatory inspections, and manage responses to audit findings
Ensure laboratory personnel are trained and qualified in GMP requirements, documentation practices, and quality procedures
Review and approve laboratory data, reports, and records in accordance with ALCOA+ data integrity principles
Partner cross-functionally with Operations, Validation, and Supply Chain to embed quality into daily workflows
Establish, monitor, and analyze quality KPIs and metrics to identify trends and drive improvement initiatives
Stay current on evolving regulatory expectations and industry best practices; proactively recommend system or procedural enhancements
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, Biology, or a related scientific discipline
3–5+ years of experience in a GMP-regulated laboratory environment, including at least 2 years in a quality leadership or supervisory role
Strong working knowledge of GMP, GLP, FDA, and ICH guidelines
Demonstrated experience overseeing product quality testing, data review, and quality systems
Proven track record leading audits, inspections, investigations, and CAPA programs
Experience managing or mentoring quality or laboratory staff
High level of attention to detail with the ability to balance compliance with operational efficiency
Comfortable working in a small-company, fast-paced environment where initiative and collaboration are critical
Experience with LIMS and electronic quality/document control systems preferred
Preferred
Bachelor's degree with a Chemistry focus or Chemistry experience
Strong technical background in microbiology and/or chemistry testing
Experience working with or safely handling pathogenic microorganisms
Proficiency with Microsoft Office and laboratory documentation tools
Ability to travel to HQ for training, audits, or company events
Strong interpersonal skills with the ability to communicate clearly and effectively across teams
Commitment to maintaining a safe, compliant, 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