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Requisition ID:  19097

QA Specialist

Job Summary

The QA/QC Specialist works with the Quality Assurance Director to achieve and maintain excellence in performance within processes implemented and documented for all Office of Indiana State Chemist (OISC) employees.  The QA/QC Specialist will take a leading role in moving OISC laboratories towards ISO 17025 compliance. Primarily, the QA/QC specialist will maintain, improve, and keep current SOPs, methods, CAPAs, calibrations, change management, and training required for compliance with FDA, EPA, DEA, USDA, or Purdue policies and agreements.  In addition, the QA/QC Specialist will collaborate directly with each lab section to harmonize, develop, improve, and audit quality processes in support of nationally recognized standards or regulatory requirements. 

 

Responsibilities:

  • Develops, recommends, and implements, with approval of the Quality Assurance Director, supporting SOPs, methods, and trainings
  • Approves CAPA and change control documentation for administrative, investigative, and laboratory support activities throughout the agency
  • Prepare and maintain necessary control documentation charts and metrics
  • Perform internal audits for ISO 17025, AFRPS, and other related program compliance
  • Manage pipette, balance, temperature recorder, and other necessary calibration programs
  • Maintains knowledge of national developments regarding contracts, national groups such as FERN, EPA Region 5 and AFRPS
  • Involvement in association related quality programs with FDA, EPA, or USDA, to stay current with expected practices and national issues related to QA/QC activities
  • Serves on committees and boards of professional associations related to the position
  • Leads the OISC safety committee and quarterly safety meetings
  • Interacts with REM around proper disposal of hazardous materials and wastes, preparation of inventory reports, integrated safety audits, and other related Purdue safety requirements

Required:

  • Bachelor's Degree in chemistry, physical science, life science, Quality/ Process management related to laboratories and administrative support activities or related field 
  • 4 years of relevant experience (In addition to direct applicable work experience, active participation in AASCO, AAPCO, AAFCO, or AAPFCO may be considered experience)
  • In lieu of degree consideration will be given to an equivalent combination of related education and required experience (Associate's degree + 6 years of related experience)
  • Experience in a pharmaceutical, chemical, food science, or microbiological laboratory environment
  • Understanding of ISO 17025, ISO 9001, cGxP, verification and validation of methods and electronic records in an analytical laboratory
  • Knowledge in writing SOPs or other technical documents
  • Knowledge of standards and accreditation processes subject to an ISO 17025 standard, or similar, or cGxP compliance demonstrated by education and experience
  • Ability to assess and improve processes, evidenced by work experiences
  • Demonstrated qualities of leadership, self-motivation, compliance conscientiousness, and ability to work with others successfully as an individual or participating in a team environment
  • Evidence of or discussions regarding working in an ISO 17025 compliant environment and having worked successfully with others in support of a positive and diverse workplace environment
  • Demonstrations of ability to draft SOPs and knowledge of good implementation skills across multiple departmental units
  • Travel

 

Additional Information:

  • Purdue will not sponsor an employment related visa for this position.
  • A background check will be required for employment.
  • FLSA: Exempt (Not Eligible for Overtime)
  • Retirement Eligibility: Defined Contribution Waiting Period.
  • Purdue University is an EOE/AA employer.  All individuals, including minorities, women, individuals with disabilities, and veterans are encouraged to apply.


Nearest Major Market: Lafayette

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