Quality Control Manager

Position Overview Spectra 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. Key Responsibilities Quality Control Leadership Develop, 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 Operations Manage microbiology and analytical laboratory operations. Oversee Stability Program activities from manufacturing through product expiration. Perform oversight of microbiological testing, including: Antibiotic Testing Growth Promotion Testing USP and USP Monitor incoming chemical inspection cycle times and laboratory efficiency. Ensure timely escalation of critical laboratory deviations. Quality Systems & Compliance Manage and approve: Change Controls QC Metrics Deviations CAPAs Test Methods Specifications Laboratory improvement projects Develop and implement laboratory policies and procedures. Maintain compliance with: FDA regulations GMP requirements OSHA requirements Facility safety standards Documentation & Validation Review and approve GMP documentation, including: SOPs, Work Practices, and Associated Forms Validation Plans and Protocols IQ/OQ/PQ Documentation User Requirement Specifications Certificates of Analysis Analytical Validation Protocols and Reports Methods and Specifications Change Requests Deviations, Investigations, and CAPAs Leadership & Staff Development Lead 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 & Experience Required Bachelor'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. Preferred Lean Six Sigma Certification. Technical Qualifications Thorough knowledge of quality control standards and testing methodologies. Experience with: HPLC GC FTIR Wet Chemistry Viscometers pH instrumentation Autotitrators Other laboratory instrumentation Proficiency with Microsoft Office, particularly: Outlook Teams Excel Professional Skills Sound decision‑making Leadership and team management Planning and organization Effective communication Problem‑solving Adaptability Integrity and confidentiality Initiative and continuous improvement Reliability and accountability Ability to manage multiple priorities in a fast‑paced environment Physical Requirements Remain 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. 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. #J-18808-Ljbffr Spectra Tech, Inc.