Laboratory Quality Control Senior Manager

Swisher•Jacksonville, FL

2h•Onsite

About The Position

The Laboratory Quality Control Manager leads the implementation, operational readiness, and day-to-day management of Swisher’s centralized quality control laboratory for finished-product release testing. This role establishes and maintains the people, methods, equipment, procedures, quality systems, and external partnerships needed to generate accurate, reliable, traceable, and defensible data for product disposition in a regulated manufacturing environment.

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Chemical Science, or a related scientific field
8–10 years of experience in an analytical or quality control laboratory, including significant experience in a regulated laboratory or manufacturing environment
2+ years of experience leading laboratory personnel and managing day-to-day laboratory operations
Experience managing equipment qualification and calibration, SOPs and controlled methods, data integrity, investigations, training, and laboratory readiness
Working knowledge of quality control testing, method validation and verification, laboratory result review and reporting, precision measurement, and quality-improvement practices
Strong leadership, coaching, organizational, analytical, problem-solving, and decision-making skills
Ability to communicate technical information clearly, manage competing priorities, meet deadlines, and collaborate effectively across functions
Demonstrated commitment to laboratory safety, accurate documentation, ethical data practices, and regulatory compliance

Nice To Haves

Master's degree in Chemistry, Analytical Chemistry, Biochemistry, Chemical Science, or a related scientific field is preferred
Experience establishing, scaling, centralizing, or launching an analytical or quality control laboratory, including equipment readiness, quality-system implementation, personnel qualification, and go-live support
Experience in a regulated industry, such as pharmaceuticals, tobacco or nicotine, food and beverage, dietary supplements, medical devices, consumer goods, or a similar FDA-regulated manufacturing environment
Experience with HPLC/UHPLC laboratory operations, chromatographic testing, laboratory data systems, analytical troubleshooting, and analytical method transfer
Experience supporting finished-product release testing and product-disposition decisions
Formal training in GMP, GLP, ISO 17025, data integrity, laboratory quality systems, or related disciplines
Experience managing a multi-shift laboratory and coordinating with external laboratories for overflow or contingency testing

Responsibilities

Lead the transfer of analytical testing methods and capabilities from third-party laboratories to the Swisher QC laboratory, including transfer protocols, knowledge transfer, training, documentation, and resolution of technical issues
Lead implementation and operational readiness of the centralized quality control laboratory, including startup planning, workflow design, and coordination of readiness activities through go-live
Partner with Quality Assurance, Research and Development, Engineering, Facilities, EHS, Operations, Procurement, and other stakeholders to finalize laboratory space, utilities, layout, safety, and operating requirements
Coordinate the selection, procurement, installation, commissioning, qualification, calibration, and operational readiness of HPLC/UHPLC systems and other laboratory equipment
Establish laboratory quality systems, including controlled test methods, SOPs, forms, training records, data-review practices, investigation processes, and document controls
Coordinate method qualification, validation or verification, personnel qualification, and parallel testing with third-party laboratories; assess comparability results and support go-live decisions for in-house product-release testing
Support the recruitment, onboarding, training, and qualification of laboratory personnel, and establish staffing, coverage, and workflow plans for a multi-shift testing operation
Establish capacity, inventory, vendor, service, equipment-redundancy, and contingency plans to support current testing demand, future growth, and continuity of product-release testing
Maintain qualified third-party laboratory relationships for overflow, contingency, specialized testing, calibration, and technical support as testing capabilities transition in-house
Lead daily laboratory operations, including workflow, staffing, prioritization, and shift coverage, to meet testing and product-release requirements
Manage, coach, train, and develop laboratory personnel; assign work, monitor performance, set expectations, and maintain documented personnel qualifications
Develop, implement, maintain, and continuously improve laboratory procedures, controlled test methods, SOPs, and supporting records
Oversee routine analytical testing and technical review to ensure the accuracy, integrity, traceability, and reliability of laboratory data and results
Maintain transferred analytical methods after go-live through ongoing qualification, verification, validation, comparability assessment, and controlled change management
Manage the laboratory equipment lifecycle, including selection, procurement support, installation, qualification, calibration, preventive maintenance, troubleshooting, service coordination, and readiness of HPLC/UHPLC systems and related equipment
Investigate out-of-specification, out-of-trend, failed system-suitability, data-integrity, calibration, and other laboratory events; ensure timely documentation, root-cause analysis, corrective action, escalation, and closure
Maintain inspection and audit readiness by ensuring compliance with applicable regulatory requirements, quality systems, laboratory practices, safety expectations, and document-control standards
Monitor laboratory capacity, turnaround time, workload, supply usage, and operational performance; identify trends, risks, and constraints and communicate them to management
Manage laboratory supplies, standards, reagents, reference materials, consumables, and inventory, including vendor coordination and appropriate storage and control
Evaluate and recommend technologies, methods, equipment, and process improvements that enhance quality, reliability, efficiency, scalability, and cost management
Partner with Quality Assurance, Operations, Research and Development, Engineering, EHS, Procurement, and external laboratories to support testing, investigations, method transfer, overflow, contingency planning, and laboratory readiness
Support departmental planning and budget administration, including staffing and resource needs, equipment and supply costs, vendor relationships, and approved operating priorities
Maintain a safe, organized, and compliant laboratory environment, and ensure required safety procedures and training are consistently followed