To perform daily quality control activities under the direction and supervision of the Quality Manager. PRIMARY DUTIES AND RESPONSIBILITIES:
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- Will assist the Quality Manager with all quality operations and responsibilities at the Pain Management facility.
- Ensure compliance to procedures and address non-compliance issues.
- Will assist the Quality Manager in conducting internal audits of processes, systems and procedures.
- Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.
- Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures.
- Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process.
- Will assist Quality Manager in assuring the timely closure of incident complaints.
- Write, review and revise SOP's as needed to assure compliance and continuous improvement.
- 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.
- 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).
- Will perform review of quality related documents generated at the facility.
- Other duties and responsibilities as assigned.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY 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.
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