What are the responsibilities and job description for the ISO Quality Manager - DNA Analysis and Molecular Biology Manufacturing position at EdenRoc Sciences?
Located in the beautiful Santa Cruz Mountains in California, EdenRoc Sciences two subsidiaries are looking for a Quality Manager to focus on our ISO certificaiton. Each of the two businesses share lab and office space and utilize DNA sequencing for their kits and services.
Job Description
Astrea Forensics and Claret Bioscience, and are sister companies that share office/lab space. Claret Bioscience produces reagents that Astrea Forensics uses to improve the recovery of forensic DNA data.
Under the direct supervision of the Laboratory Director, the Quality Manager is responsible for the implementation and maintenance of the Quality Management Systems for Astrea and Claret. This includes ensuring accreditation compliance, writing foundational documents, as well as coordinating the planning, development, and administration of quality assurance activities.
Duties:
- Coordinate the development and author the foundational documents of the quality management system in compliance with all accrediting standards held and pursued by Astrea Forensics and Claret Bioscience
- Ensure the laboratories remains in compliance with all applicable accreditation standards
- Perform supplier evaluations, CAPA processes, and all other documentation needed to maintain a healthy ISO accreditation
- Conducts period audits to provide management with the necessary verification that established quality policies and objectives are being met
- Ensure the policies and objectives are documented, communicated, and understood, when implemented
- Advises management regarding the development, implementation, and maintenance of the quality system as well as lead quarterly ISO management meetings
- Authorize laboratory personnel to perform casework (Astrea specific)
- Approve the selection and establishment of the criteria of analytical methods/procedures within the laboratory, and as necessary, review and update methods and procedures
Minimum Requirements:
- A baccalaureate or advanced degree in a chemical, physical, or biological science or forensic science.
- Detailed experience and working knowledge of ISO 9001:2015, ISO 13485:2016, and/or ISO 17025:2017 accredited Quality Management systems
- Management and/or supervisory experience
Preferred Experience Requirements:
- DNA analysis experience
- Internal Auditor experience for ISO 9001:2015, ISO 13485:2016, and/or ISO 17025:2017
Astrea Forensics and Claret Bioscience are EdenRoc Sciences companies. We understand that our difference makes us stronger and consider all candidate regardless of their age, sex, race or other protected categories. We offer generous paid time off and Fortune 500-level benefits. We look forward to reviewing your resume and cover letter.
