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Quality Assurance Manager

2 months ago

Norcross, United States Micromeritics Full time
Job DescriptionJob DescriptionSalary:

POSITION SUMMARY:

The Quality Assurance Manager works with the PTA Laboratory Manager and lab employees to make sure that PTA complies with ISO, FDA, CFR's, and GMP/GLP guidelines and that all appropriate documentation is maintained.


ESSENTIAL FUNCTIONS:

  • Perform quality reviews and approval of lab test data.
  • Responsible for the maintenance of quality standards in laboratory operations.
  • Generate, revise, and/or update all SOPs to ensure that PTA complies with all applicable SOP and/or ISO procedures.
  • Perform quality audits, assist external organizations by providing requested data, and reviews findings with PTA Laboratory Manager to ensure compliance
  • Ensure that PTA staff are appropriately trained on SOPs, procedures and regulatory subjects. Ensure PTA Staff training records are accurate and kept up to date.
  • Ensure that reference data for all instruments are scheduled and processed in a timely manner and within the required time restraints for final processing and signoff.
  • Incorporate blind studies within the laboratory to ensure the highest level of quality is being maintained on an unbiased basis.
  • Maintain and update all instrument maintenance logbooks and ensure that all logbooks and/or all appropriate documentation are stored properly for internal and external audit purposes.
  • Responsible for managing documentation and scheduling all instrument installations (IQ/OQ), uninstalls, repairs, and planned maintenance (PM).
  • Respond to Out-Of-Specification reports for instrumentation and customers as well as maintain these entries within the database.
  • Record and maintain Corrective Action and Preventive Action records the details of any findings to ensure that resolutions are addressed and cleared in a timely manner.
  • Implements general house-keeping procedures as well as coordinates with MIC Maintenance and IT Departments in regards to PTA.
  • Coordinates calibration of PTA laboratory equipment (annual PM service).
  • Facilitate QIT meetings and record minutes follow-up on related issues as needed.
  • Complies with all applicable PTA SOP’s, ISO 17025 procedures, cGMP and FDA requirements.
  • Other duties as assigned.


EDUCATION:  Bachelor of Science in Chemistry, Materials Science, or similar education equivalent.


EXPERIENCE:  Three to five (3-5) years of lab experience working in an analytical or testing lab is required, either within PTA or similar business. Knowledge of ISO 17025, cGMP guidelines and FDA requirements is required. Experienced quality manager with internal and customer auditing desired.


SKILLS & KNOWLEDGE: Self-directed, highly motivated individual. Strong organizational, project management, planning and prioritization skills are required. Must have excellent computer, verbal and written communication skills.