Position OverviewSpectra 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 ResponsibilitiesQuality 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 & ValidationReview 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 & ExperienceRequired- 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:
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.
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
