Position Summary | Investigate process deviations, propose and implement effective CAPA, perform on the floor batch record review and monitor and measure ongoing performance of Manufacturing quality systems. |
Duties and Responsibilities | - Determine accurate root cause
- Drive investigations to successful resolution
- Cultivate strong interdepartmental working relationships
- Track CAPA/Deviation owners to ensure on time completion
- Issue reports and track metrics of all open manufacturing deviations, investigations, excursions, and corrective and preventative actions (CAPA)
- Keep various quality and efficiency metrics as directed by manufacturing management
- Facilitate the accurate and timely completion of manufacturing review of executed batch records, ensure batch records are completed in accordance with company SOPs, cGMPs, and customer specifications
- Assist in the correction of deficiencies found within the documentation reviewed
- Facilitate sound discussions on training adequacy and CAPA effectiveness
- Other duties as required by management
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Regulatory Responsibilities | - Conduct business in a responsible manner that complies with all state, OSHA and HIPAA regulations
- Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
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Supervisory Responsibilities | |
Experience | - Two (2) years of work experience in pharmaceutical, IVD or Medical Device based cGMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools preferred
- Experience with equipment calibration and investigation of out of tolerance (OOT) preferred
- Prior batch record experience preferred
- Specific education/degree may be considered in lieu of above timeframes
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Education | - Associates degree preferred
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Knowledge, Skills & Ability | - In-depth knowledge of FDA regulations and cGMP systems
- Applied knowledge of quality by design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products
- Excellent oral and written communication skills
- Strong technical writing ability
- Familiarity with manufacturing batch records
- Able to work independently with minimal supervision and direction
- Proficiency with computer systems including MS Office (Outlook, Word and Excel)
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Physical Requirements | - Frequent standing and walking throughout the facility
- Stretches of sitting and typing
- Satisfactory audio-visual acuity
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