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  1. Review and approve supplemental logs, charts and other documents in support of cGMP operations.
  2. Review batch records and certificates of analysis for accuracy and completion prior to final release of product.
  3. Maintain the Approved Supplier List including updating and reviewing performance of vendors.
  4. Provide quality assurance support of investigations including: nonconformance, CAPA, root cause analysis, complaints, out of specification and environmental excursions.
  5. Provide quality input and maintain the files for change controls and planned deviations.
  6. Provide document control support.
  7. Issue and reconcile batch records.
  8. Maintain device history files.
  9. Perform internal and external audits as assigned.
  10. Assist in the maintenance and implementation of the Quality System.
  11. Perform Material Master data transactions in the ERP system, specifically SAP.
  12. Participate in project teams and perform other related duties as assigned.
  13. Responsible for other duties and projects as assigned.


Required Qualifications:

  1. Bachelor’s Degree required, preferably in the life sciences or relevant experience.
  2. 5+ years industry experience in a QA function.
  3. Knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices.
  4. Experience auditing in a GMP/ISO environment.

Desired Experience, Knowledge, and Skills:

  1. Ability to interact positively and professionally with internal and external customers.
  2. Ability to work autonomously, effectively manage time and deliver results on time.
  3. Ability to perform Materials Master Data transactions in SAP.
  4. Requires proficiency in word processing, spreadsheets, and databases.
  5. Excellent presentation skills, both written and in platform presentation format.

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