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EKF Diagnostics · 2 weeks ago

Quality Control (QC) Laboratory Manager

Boerne,TX,US

Full-time

Onsite

Senior Level

5+ years exp

EKF Diagnostics is a company focused on quality control in diagnostics. They are seeking a Quality Control (QC) Laboratory Manager to oversee the performance of the QC laboratory, ensuring compliance with quality and regulatory standards while managing laboratory personnel and processes.

Health CareHealth DiagnosticsManufacturing

No H1B

Responsibilities

Responsible for overall management strategy for Quality Control (QC) staff

Accountable for ensuring full quality and regulatory compliance of quality control analytical activities

Lead, organize and maintain all department and laboratory processes, procedures, and administrative duties

Define priorities for the QC department

Ensure alignment of QC priorities with the site priorities/strategy, also ensure strategy deployment

Plan testing and inspection activities of the QC Laboratory to meet production schedules

Manage and work with team to resolve QC non-conformances and other identified issues

Coordinate the sequence of issue resolution across the department to ensure minimal customer impact

Support root cause analysis and implement corrective actions

Identify and manage business risks & opportunities in the QC department

Foster relationships with cross functional roles on a local level

Assure adequate communication of priorities exists between the lab and other departments and within the lab

Function as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers

Develop and implement systems designed to support assay development, stability, raw material, and finished product testing

Continuous management, development, and improvement of stability program

Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples

Ensure all raw materials, bulks, and finished goods are tested in accordance with all regulatory, company, and customer requirements, as applicable

Manage method validations/qualifications

Identify and report non-conformances/deviations/out-of-specification events

Investigate deviations and write exception documents as required, utilizing problem solving tools as needed

Prepare justification for new lab equipment

Prepare purchase orders and coordinate authorization and procurement

Arrange installation and qualification

Ensure audit readiness and ensure staff members work according to established processes to be fully compliant with current Good Manufacturing Practices (cGMP)

Adhere to current Good Manufacturing Practices (cGMP); Ensure all direct reports comply

Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc

Ensure compliance with safety regulations and procedures are followed; Maintain clean and safe work area

Assist as needed in other areas of the company where training requirements have been completed

Perform other duties as assigned

Directly manage the Quality Control personnel at the Boerne site

Fulfill manager responsibilities in accordance with the organization's policies and applicable laws; Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Qualification

Quality Control ManagementCGMP ComplianceRoot Cause AnalysisLaboratory ExperienceBiologicalChemical KnowledgeChange ManagementRisk AssessmentMethod ValidationMicrosoft ExcelLeadership SkillsInterpersonal SkillsDetail OrientedOrganizational SkillsCommunication Skills