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CAPS QC Coordinator-Microbiology
| Company | B. Braun Medical Inc |
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| Location | Allentown, PA, USA |
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| Salary | $23.44 – $29.31 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- Bachelors degree required or equivalent combination of education and experience
- Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science
- Knowledge of pharmacy operations and regulatory guidelines
- Ability to perform pharmacy calculations
Responsibilities
- Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor
- Perform and/or coordinate completion of environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts
- Collect Environmental Monitoring samples as necessary
- New staff training
- Sterility tests, aseptic technique qualifications, and media fill process validations
- Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records
- Verify that raw materials meet specification limits
- Verify accuracy of labeling
- Perform final disposition of Batch
- Verify that product test results meet specification limits
- Verify that all documentation is complete
- Document non-compliance and evaluate if further investigation is needed
- Submit samples to the appropriate labs for chemical assay and microbial tests
- Track vendor equipment calibration and maintenance records and assess for deviations
- Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template
- Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
- Support Internal & External audits
- Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.)
- Participate in Director of Pharmacy’s staff meetings
Preferred Qualifications
- Minimum of 2 years experience in pharmacy preparation
- Pharmacy Technician Certification
