Job Description

This position will reside on site at the Salt Lake City laboratory. The regional Quality Manager will be responsible for supporting operational and technical supervisors and leads in all aspects of the Quality Management System. The role will also ensure timelines and quality measures are met and technicians are following SOPs. The Regional Quality Manager will be dedicated to all labs in their region. This position may have authority over local quality specialist(s) for delegated quality tasks.

• Demonstrates and promotes the company vision, mission, and quality objectives
• Regular attendance and punctuality, active participation and contributions
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Reads, understands, and follows management system requirements as relevant to responsibilities. Fully familiar with Quality Manual, policies, procedures, work instructions and methods. ISO/IEC 17025 requirements and relevant government and FDA regulatory requirements. Including but not limited to 21 CFR Part 11, 58, 111, 117, 210, 211.
• Maintains ISO certification activities for all sites in the region. This includes, but is not limited to audit scheduling and execution, scope changes, and routine communication with the accreditation body.
• Will supervise up to 5 direct reports.
• Reviews and ensures implementation of new/revised controlled documents
• Acts as a management resource for laboratory personnel and local quality responsible for correct application and interpretation of internal quality documents.
• Ensures implementation of corporate quality initiatives and provides updates on progress
• Provides leadership and actively accepts quality improvement projects of universal benefits to Eurofins based on understanding of potential opportunities
• Conducts annual (or per site SOP) assessment of all laboratories within their jurisdiction, provides constructive feedback with a detailed report.
• Regularly monitors non-conformances, derogations, deviations and complaints for trends. Assists with root cause analysis and CAPA as necessary.
• Responsible for execution of the PT program within the sites
• Responsible for monthly metric reporting requirements to group.
• Answers client service customer inquiries related to quality matters.
• Conducts the Quality Management review at each laboratory in Q1 of each calendar year.
• Coordinates and hosts all quality audits by clients or regulatory authorities. Is responsible for all follow up actions if required.
• Maintain cooperative working relationships with all company employees. Communicate orally and in writing with co-workers.
• Adhere to all health, safety, and environmental regulations relative to their position.
• Performs other duties as assigned

Qualifications

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

• Ability to learn new tasks and lead others
• Ability to think critically and solve problems
• Authorization to work in the United States indefinitely without restriction or sponsorship
• Willing to work overtime, weekends, and holidays as needed
• A minimum of 7 years experience as a quality responsible professional
• Experience working at an ISO 17025 accredited laboratory
• Willingness and ability to travel between 25-50%
• Experience in training and auditing
• Bachelor's degree in a science related field
• LIMS experience
• Thorough understanding of equipment qualifications/calibrations, method validations, process improvements, technical/SOP writing, risk analysis
• Prefer experience or coursework in laboratory procedures, data analysis, computer operations, and technical/business writing
• Previous experience in a production style laboratory preferred
• Prior experience with QA/QC programs an important advantage
• Strong understanding of corrective action
• Excellent interpersonal/communication skills
• Self-motivated and driven critical thinker able to work at a high pace and rapidly changing environment
• Reside within a commutable distance to Salt Lake City, UT lab.

Additional Information

What we offer: As an employer, we're keen to look after our people with as much dedication as they look after our patients. That's why we offer competitive salaries, excellent training and exceptional career prospects. We're a growing and ambitious company, so there is huge potential here to develop with us and enjoy fantastic rewards in your career.

Your data:
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