Quality Associate
Location:
Sugar Land , Texas
Posted:
February 03, 2017
Reference:
00001H5C
POSITION SUMMARY:


To perform daily quality control activities under the direction and supervision of the Quality Manager.

PRIMARY DUTIES AND RESPONSIBILITIES:
  1. Will assist the Quality Manager with all quality operations and responsibilities at the Pain Management facility.

  2. Ensure compliance to procedures and address non-compliance issues.

  3. Will assist the Quality Manager in conducting internal audits of processes, systems and procedures.

  4. Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.

  5. Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures.

  6. Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process.

  7. Will assist Quality Manager in assuring the timely closure of incident complaints.

  8. Write, review and revise SOP's as needed to assure compliance and continuous improvement.

  9. Will assist in the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports.

  10. Will coordinate and schedule testing of all product for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner).

  11. Will perform review of quality related documents generated at the facility.

  12. Other duties and responsibilities as assigned.




Qualifications:
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
  • 1 - 3 years experience in Quality, Operations, or related field in the healthcare industry. BS in science or related field is desired.

  • Basic PC skills including MS Word and Excel.

  • Demonstrated understanding of quality assurance in a regulated environment.

  • Effective problem solving, strong communication (written and verbal) and organizational skills.



MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

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