Regional Quality Manager - Salt Lake City, UT (On-site)

Eurofins USA Food Testing•Salt Lake City, UT

4d•Onsite

About The Position

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.

Requirements

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
Reside within a commutable distance to Salt Lake City, UT lab.

Nice To Haves

Experience or coursework in laboratory procedures, data analysis, computer operations, and technical/business writing
Previous experience in a production style laboratory preferred
Prior in-depth experience working in an ISO 17025 accredited testing laboratory
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

Responsibilities

Support operational and technical supervisors and leads in all aspects of the Quality Management System.
Ensure timelines and quality measures are met and technicians are following SOPs.
Maintain ISO certification activities for all sites in the region, including audit scheduling and execution, scope changes, and routine communication with the accreditation body.
Supervise up to 5 direct reports.
Review and ensure implementation of new/revised controlled documents.
Act as a management resource for laboratory personnel and local quality responsible for correct application and interpretation of internal quality documents.
Ensure implementation of corporate quality initiatives and provide updates on progress.
Provide leadership and actively accept quality improvement projects of universal benefits to Eurofins.
Conduct annual assessment of all laboratories within their jurisdiction, providing constructive feedback with a detailed report.
Regularly monitor non-conformances, derogations, deviations and complaints for trends.
Assist 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.
Answer client service customer inquiries related to quality matters.
Conduct the Quality Management review at each laboratory in Q1 of each calendar year.
Coordinate and host all quality audits by clients or regulatory authorities.
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.
Perform other duties as assigned.