Quality Assurance Coordinator

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

 Group's key figures (as of March 2019) are approx. 4.56 billion Euros, over 800 laboratories across 47 countries and about 45,000 staff.

Job Description

Eurofins Test America is searching for a Quality Assurance Coordinator in Sacramento, CA.

The Quality Assurance (QA) Coordinator reports directly to a QA Manager that has been assigned overall responsibility for Quality Systems at a facility. The QA Coordinator assumes the QA Manager role when the quality assurance manager is absent or unavailable at that facility. The Quality Assurance (QA) Coordinator has the authority for and responsibility of, implementing, and improving the facility’s Quality System that meets the requirements set forth in the Eurofins TestAmerica Quality Management Plan (QMP). Responsibilities include providing Quality Systems training to all new personnel; maintaining a laboratory Quality Assurance Manual (QAM); arranging and managing proficiency testing (PT) samples; and performing systems, data, special, and external audits with both clients and regulatory officials. The QA Coordinator oversees the maintenance of quality control (QC) records; maintains certifications; approves, develops, and maintains Standard Operating Procedures (SOPs); submits QA Reports; and assists in reviewing new work as needed. The QA Coordinator has the final authority to accept or reject data, and to stop work in progress in the event that procedures or practices compromise the validity and integrity of analytical data. The QA Coordinator is available to any employee at the facility to resolve data quality or ethical issues. As directed by the QA Manager, coordinates the activities of the QA staff.

Quality Assurance Coordinator responsibilities include, but are not limited to, the following:

·         In the absence of or as directed by the QA Manager, supervise and coordinate the activities of the QA staff. Serve as a resource to all laboratory personnel on QA issues.

·         Review Eurofins TestAmerica’s QMP and ensure compliance with the Eurofins TestAmerica Quality System

·         Work with the QA Manager to develop and implement the QAM.

·         In the absence of or as directed by the QA manager, act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.

·         In the absence of or as directed by the QA manager, Act as a technical resource and final authority in all matters of data quality

·         In the absence of or as directed by the QA manager, Act as the focal point for ethics and data integrity issues.

·         Conduct and/or oversee QA training courses. As directed by the QA Manger, may conduct ethics training minimally every quarter in which new employees are hired

·         Evaluate the thoroughness and effectiveness of the laboratory’s training program

·         Perform system audits of each department, write audit reports, and approve audit responses

·         Perform data audits

·         Perform special audits as deemed necessary by data audits, client inquiries, etc.

·         Conduct and respond to external audits conducted by clients and regulatory agencies

·         Work with management in performing annual Management Review of the Quality System

·         Assist in reviewing and/or writing of Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals.

·         Maintain all necessary laboratory certifications

·         Manage scheduling, ordering, login, and reporting of PT samples

·         Monitor new regulations, communicate them to the laboratory, and ensure compliance with the current version of regulations

·         Review and approve laboratory SOPs. Write SOPs as needed·       

·         Perform or arrange for calibration of laboratory support equipment which may include balances, weights, and thermometers

·         As directed by the QA Manager, assist other laboratories as needed, including performing systems audits of other Eurofins TestAmerica laboratories.

The ideal candidate would possess:

·         Environmental methodologies

·         General environmental regulatory requirements

·         Analytical laboratory techniques

·         Laboratory QA requirements

·         Statistical principles

·         Knowledge of computers, spreadsheets, and databases

·         Experience with technical writing 

·         Problem solving skills

·         Supervisory skills

·         Ability to communicate effectively at all levels of organization, as well as with clients and outside agencies

·         Ability to analyze problems and effect solutions

·         Ability to prioritize

·         Must be able to evaluate data objectively and perform assessments without outside (i.e., managerial) influence

·         Strong computer, scientific, and organizational skills

·         Excellent communication (oral and written) and attention to detail

Position is full-time, Tues-Sat, 8 a.m.-5 p.m., with additional hours as needed.  Candidates currently living within a commutable distance of Sacramento, CA are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off days, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com

Qualifications

Basic Minimum Qualifications:

·         BS/BA in Chemistry or related field from an accredited university

·         Minimum 3 years bench level analytical experience plus formal QA training or 2 years QA experience.

·         Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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