Jobs · Quality Assurance · Arizona

Quality Assurance Manager, Eurofins Environment Testing Southwest, Phoenix, AZ

Eurofins Viracor BioPharma Services · Phoenix, AZ · 1 mo ago
Quality Assurance$50k–$70k/yrFull-time

About the role

Eurofins Environment Testing Southwest is seeking a Quality Assurance Manager to develop, implement, and improve the laboratory Quality System that meets the requirements set forth in the Eurofins Environment Testing Quality Management Plan (QMP). The QA Manager is independent of laboratory operations and serves as the final authority on data quality and integrity.

Responsibilities

  • Review and ensure compliance with the Eurofins Environment Testing QMP and Quality System
  • Develop and implement the laboratory Quality Assurance Manual (QAM)
  • Participate as a member of the laboratory’s senior management team and act as the QA representative in client and regulatory meetings
  • Serve as the technical resource and final authority on all matters of data quality and ethics
  • Conduct and/or oversee QA training courses, including ethics training at least quarterly for new hires
  • Evaluate the thoroughness and effectiveness of the laboratory’s training program
  • Perform system audits of each department, write audit reports, and approve audit responses
  • Conduct data audits and special audits as needed based on data audits, client inquiries, etc.
  • Conduct and respond to external audits by clients and regulatory agencies
  • Work with management to perform the annual Management Review of the Quality System
  • Assist in reviewing and/or writing Quality Assurance Project Plans, technical and QC specifications in contracts and proposals
  • Maintain all necessary laboratory certifications
  • Manage scheduling, ordering, login, and reporting of proficiency testing (PT) samples
  • Monitor new regulations, communicate them to the laboratory, and ensure compliance with current versions
  • Review and approve laboratory SOPs; write SOPs as needed
  • Maintain historical indices of all technical records (SOPs, audits, ancillary equipment calibration, logbook distribution, etc.)
  • Assist in monitoring laboratory compliance with reference methods, SOPs, and agency-specific requirements
  • Maintain training records, including Demonstrations of Capability (DOCs) for all analysts
  • Assist in identifying 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 ensure implementation of appropriate corrective action
  • Track revised reports and assist in identifying systematic improvements to minimize errors
  • Track customer complaints and assist in identifying improvements
  • Oversee and approve method detection limit (MDL) studies and verifications
  • Generate and submit monthly QA reports; participate 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 (e.g., balances, weights, thermometers)
  • Assist other laboratories as needed, including performing systems audits of other Eurofins Environment Testing laboratories

Qualifications

  • BS/BA in Chemistry or Sciences
  • 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
  • Professional working proficiency in English (ability to read, write, and speak)

Minimum Skills and Abilities

  • Knowledge of environmental methodologies and general regulatory requirements
  • Proficiency with analytical laboratory techniques and laboratory QA requirements
  • Understanding of statistical principles
  • Proficiency with computers, spreadsheets, and databases
  • Strong technical writing, organizational, time management, problem-solving, and supervisory skills
  • Ability to communicate effectively at all levels of the organization, with clients, and outside agencies
  • Ability to analyze problems and effect solutions
  • Ability to prioritize tasks and manage multiple responsibilities

The compensation range for this position is $50,000–$70,000 per year depending on experience. This is a full-time, exempt position with a Monday through Friday day shift schedule.

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