Quality Control Manager

Quality Control ManagerSpectra Tech, Inc. is seeking a Quality Control Manager to oversee Quality Control operations within microbiology and analytical laboratories. This position is responsible for ensuring compliance with FDA regulations, GMP requirements, quality systems, and customer expectations while leading laboratory operations, personnel, method validations, and continuous improvement initiatives.Quality Control LeadershipDevelop, implement, and monitor Quality Control processes, personnel, and laboratory methods.Ensure raw materials, in-process testing, reagents, and finished products comply with regulatory, quality, and customer requirements.Exercise sound judgment when interpreting quality requirements and making compliance decisions.Properly manage and execute Quality Control verifications, inspections, testing, and analyses.Develop quality metrics and oversee laboratory improvement initiatives.Laboratory OperationsManage microbiology and analytical laboratory operations.Oversee Stability Program activities from manufacturing through product expiration.Perform oversight of microbiological testing, including: Antibiotic TestingGrowth Promotion TestingUSP <60> and USP <61> Monitor incoming chemical inspection cycle times and laboratory efficiency.Ensure timely escalation of critical laboratory deviations.Quality Systems & ComplianceManage and approve: Change ControlsQC MetricsDeviationsCAPAsTest MethodsSpecificationsLaboratory improvement projectsDevelop and implement laboratory policies and procedures.Maintain compliance with: FDA regulationsGMP requirementsOSHA requirementsFacility safety standardsDocumentation & ValidationReview and approve GMP documentation, including:SOPs, Work Practices, and Associated FormsValidation Plans and ProtocolsIQ/OQ/PQ DocumentationUser Requirement SpecificationsCertificates of AnalysisAnalytical Validation Protocols and ReportsMethods and SpecificationsChange RequestsDeviations, Investigations, and CAPAsLeadership & Staff DevelopmentLead and manage Quality Control personnel.Establish performance expectations and conduct employee evaluations.Train and mentor laboratory staff.Approve payroll and employee time off.Schedule workflow and standardize testing procedures.Assist with troubleshooting laboratory issues.Develop and implement Good Laboratory Practices (GLPs).Support and train personnel in microbiological and analytical testing.Education & ExperienceRequiredBachelor's degree in Chemistry.Minimum 5 years of experience in a GMP pharmaceutical environment.Experience with analytical and microbiology laboratory equipment and testing.Proven experience as a Quality Control Manager or in a similar leadership role.Strong critical thinking and problem-solving skills.PreferredLean Six Sigma Certification.Technical QualificationsThorough knowledge of quality control standards and testing methodologies.Experience with: HPLCGCFTIRWet ChemistryViscometerspH instrumentationAutotitratorsOther laboratory instrumentationProficiency with Microsoft Office, particularly: OutlookTeamsExcelProfessional SkillsSound decision-makingLeadership and team managementPlanning and organizationEffective communicationProblem-solvingAdaptabilityIntegrity and confidentialityInitiative and continuous improvementReliability and accountabilityAbility to manage multiple priorities in a fast-paced environmentPhysical RequirementsRemain in a stationary position approximately 50% of the workday.Occasionally move throughout office, laboratory, and production areas.Operate computers and laboratory equipment.Reach items at various heights.Occasionally lift up to 10 pounds.At Spectra Tech, Inc., our recruitment team is powered by real people in real time—personally reviewing every application with care and integrity. We take pride in identifying and recruiting top-tier talent while maintaining full alignment with federal regulations, EEOC standards, and fair hiring practices that reflect our commitment to excellence and equity.Spectra Tech, Inc. is committed to hiring and retaining a diverse workforce. We are an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. We are also an E-verify employer.