Job Summary
The Quality Manager is responsible for ensuring that the laboratory maintains compliance with all relevant regulations and standards, including ISO 17025, TNI 2016, AIHA, CA ELAP, VELAP, and WA DOE. This role involves overseeing quality assurance and control processes, conducting internal audits, managing proficiency testing, and maintaining laboratory certifications. The Quality Manager will also be the primary point of contact for external audits and will ensure that all laboratory practices align with established standard operating procedures (SOPs).
Key Responsibilities
- Compliance and Regulations
- Read and understand ISO 17025 and TNI 2016 regulations to maintain QA/QC in the lab
- Familiarize with AIHA, CA ELAP, VELAP, and WA DOE policies and procedures that exceed the aforementioned standards
- Review laboratory SOPs to ensure adherence and update them as necessary
- Ensure compliance with continuing Method Detection Limit (MDL) and Reporting Limit Verification (RLV) studies
- Quality Assurance and Control
- Monitor and maintain QC requirements for all laboratory methods
- Manage Proficiency Testing (PT) schedules and data entry for all labs
- Perform data reviews and audits to ensure compliance with methods and standards
- Conduct weekly document scans and reviews for each laboratory
- Support equipment verification compliance, including quarterly pipette verification and annual balance and thermometer verification
Audits and Corrective Actions
- Conduct internal audits for all laboratories as per the current cycle (CA ELAP, AIHA, WA, and VA)
- Maintain a CAPA (Corrective and Preventive Actions) log, perform root cause analysis, and ensure corrective actions are implemented and effective
- Act as the primary contact for external audits and ensure timely audit response and compliance
- Training and Documentation
- Provide annual ethics training and maintain all training records
- Review and approve laboratory SOPs biannually and update them as required
- Ensure proper documentation and record-keeping in compliance with laboratory standards
Management and Reporting
- Coordinate and conduct the annual management meeting in December
- Ensure all lab certifications are maintained and updated on the website and in each lab location
Requirements
- Bachelor’s degree in Chemistry, Biology, or a related field; advanced degree preferred
- Minimum of 5 years of experience in a laboratory setting, with at least 3 years in a QA/QC role
- Thorough understanding of ISO 17025, TNI 2016, AIHA, CA ELAP, VELAP, and WA DOE regulations
- Strong knowledge of laboratory methods and SOPs
- Excellent organizational and documentation skills
- Ability to conduct detailed audits and data reviews
- Proficient in using laboratory management software and Microsoft Office Suite
- Strong communication and interpersonal skills
Preferred Qualifications
- Certification in Quality Management or related fields
- Experience with proficiency testing and internal/external audits
- Familiarity with laboratory information management systems (LIMS)
- Working Conditions
- This position may require occasional travel to various laboratory locations
- The role involves working in a laboratory environment, which may include exposure to hazardous materials
Equal Opportunity Employer
Metropolitan Solutions is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.