Eurofins Test America is searching for a Quality Assurance Manager in Pittsburgh, PA
The Quality Assurance (QA) Manager has the authority for and responsibility of developing, implementing, and improving the laboratory 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 Manager oversees the maintenance of quality control (QC) records; maintains certifications; approves, develops, and maintains Standard Operating Procedures (SOPs); submits monthly QA Reports; and assists in reviewing new work as needed. The QA Manager 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 Manager is available to any employee at the facility to resolve data quality or ethical issues. The QA Manager is independent of laboratory operations.
Quality Assurance Manager responsibilities include, but are not limited to, the following :
Lead team, schedule, and train employees
Ensure adherence to highest quality and efficiency standards in laboratory operations
Ensure coverage and performance
Foster morale and teamwork
Supervises QA Staff
Review Eurofins TestAmerica's QMP and ensure compliance with the Eurofins TestAmerica Quality System
Develop and implement the QAM
Participate as a member of the laboratory's senior management team.
Act as a technical resource and final authority in all matters of data quality
Act as the focal point for ethics and data integrity issues.
Conduct and/or oversee QA training courses. As directed by the Laboratory Director, 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
Maintain historical indices of all technical records (e.g. SOPs, audits, ancillary equipment calibration, logbook distribution, etc.)
Assist in and monitor laboratory's compliance with the reference methods, SOPs, and agency-specific requirements
Maintain training records, including Demonstrations of Capability (DOCs) for all analysts
Assist in identification of systematic problems within the laboratory. Perform root cause analysis investigations in response to audit findings, client complaints, training needs assessments, data recall events, etc. Recommend resolutions for ongoing or recurring nonconformance, and ensures implementation of appropriate corrective action
Track revised reports, and assist in identifying systematic improvements to minimize errors
Track customer complaints and assists in identifying improvements
Oversee and approve method detection limit (MDL) studies and verifications
Generate and submit monthly QA reports
Participates on QA conference calls
Oversee generation of control charts and control limits, update of reference tables
Perform or arrange for calibration of laboratory support equipment which may include balances, weights, and thermometers
Assist other laboratories as needed, including performing systems audits of other Eurofins TestAmerica laboratories
Act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.
The ideal candidate would possess :
Environmental methodologies
General regulatory requirements
Analytical laboratory techniques
Laboratory QA requirements
Statistical principles
Knowledge of computers, spreadsheets, and databases
Computer skills and databases
Experience with technical writing
Time management and problem solving skills
Ability to communicate effectively at all levels of organization, clients and outside agencies
Analyze problems and effect solutions
Ability to prioritize
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Strong leadership, initiative, and teambuilding skills
Basic Minimum Qualifications :
BS/BA in Chemistry/Sciences from an accredited university
Minimum 5 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
Position is full-time, Monday-Friday, with overtime as needed. Candidates currently living within a commutable distance of Pittsburgh, PA 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 and vacation, personal days, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
