QC Laboratory Manager

Candidates must currently reside within a reasonable commuting distance of the worksite. Relocation candidates will not be considered. Candidates must be authorized to work in the United States without current or future employer sponsorship. Visa sponsorship is not available for this position. This position is not open to Corp-to-Corp (C2C) arrangements. Only candidates eligible for a W-2 employment arrangement will be considered. The Quality Control (QC) Laboratory Manager is responsible for overseeing daily laboratory operations, ensuring accurate and timely testing, regulatory compliance, and continuous improvement of laboratory processes. This role provides leadership to laboratory personnel while maintaining high standards of product quality, data integrity, and operational efficiency. The QC Laboratory Manager oversees analytical testing, laboratory investigations, equipment compliance, and quality systems while collaborating with cross-functional teams to support manufacturing operations, product release, and regulatory readiness. Schedule: business hours of 8:00am-5:00pm Monday through Friday. Salary range is $95,000-105,000 annually Key Responsibilities Laboratory Operations & Compliance Manage daily QC laboratory operations, including chemical, microbiological, stability, and environmental monitoring testing, as applicable.Ensure timely and accurate testing of raw materials, in-process samples, finished products, and stability samples to support manufacturing and product release.Maintain compliance with cGMP, FDA regulations, USP standards, ICH guidelines, and internal quality procedures.Oversee laboratory scheduling, staffing, workload distribution, and resource allocation to meet operational objectives.Ensure laboratory equipment, instrumentation, and computerized systems are properly qualified, calibrated, validated, and maintained.Maintain accurate laboratory documentation, testing procedures, specifications, and records in accordance with regulatory and data integrity requirements. Quality Systems & Investigations Lead and approve laboratory investigations involving Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, atypical results, and laboratory errors.Oversee root cause investigations, corrective and preventive actions (CAPA), change controls, and risk assessments.Review and approve laboratory documentation, analytical method validations, and quality-related records.Monitor laboratory performance, quality trends, and key quality indicators (KQIs) to identify potential risks and improvement opportunities.Ensure adherence to ALCOA+ data integrity principles and electronic record requirements. Team Leadership & Development Lead, mentor, and develop laboratory analysts, technicians, and other QC personnel.Establish performance expectations, conduct evaluations, and identify training and development opportunities.Ensure laboratory personnel are properly trained and qualified to perform assigned testing and responsibilities.Promote a culture of accountability, regulatory compliance, teamwork, and continuous improvement. Regulatory Readiness & Continuous Improvement Lead laboratory preparation and participation in FDA inspections, customer audits, internal audits, and other regulatory assessments.Serve as a key laboratory representative during inspections and ensure timely resolution of audit observations.Identify and implement process improvements to enhance laboratory efficiency, testing accuracy, productivity, and compliance.Support analytical method development, validation, transfers, troubleshooting, and new product introductions.Collaborate with Quality Assurance, Manufacturing, Maintenance, Supply Chain, and external laboratories to support business objectives. Budget & Resource Management Manage laboratory budgets, operating expenses, staffing plans, and capital equipment needs.Assess laboratory capacity and recommend improvements to equipment, personnel, and infrastructure.Implement cost-effective solutions while maintaining product quality and regulatory compliance.Perform additional responsibilities as needed to support laboratory and organizational goals. Qualifications Education Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline required.Master's degree preferred. Experience 5–7 years of progressive Quality Control laboratory experience within the pharmaceutical, OTC, medical device, biotechnology, or related regulated manufacturing industry.3–5 years of supervisory or management experience in a GMP-regulated laboratory environment.Demonstrated experience with laboratory investigations, regulatory inspections, analytical method validation, and quality management systems. Knowledge, Skills & Abilities Strong understanding of cGMP, FDA regulations, USP standards, ICH guidelines, and laboratory data integrity requirements.Experience with chromatography systems, analytical instrumentation, laboratory software, and electronic quality management systems (eQMS).Knowledge of OOS/OOT investigations, CAPA, root cause analysis, change control, and laboratory compliance.Proven ability to lead laboratory teams, manage competing priorities, and drive operational improvements.Strong analytical, problem-solving, organizational, and decision-making skills.Excellent written and verbal communication skills with the ability to collaborate across departments.Proficiency in Microsoft Office and laboratory information management systems.