CAPS® (Central Admixture Pharmacy Services, Inc.) · 1 day ago
CAPS QC Coordinator
B. Braun Medical Inc. is a leader in infusion therapy and pain management, dedicated to enhancing patient safety. The CAPS QC Coordinator will ensure compliance with CAPS Standard Operating Procedures and perform various quality control tasks, including environmental monitoring and documentation, training, and supporting audits.
Pharmaceuticals
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
Qualification
Required
B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science
Preferred
Minimum of 2 years experience in pharmacy preparation
Pharmacy Technician Certification
Benefits
Healthcare
401(k) plan
Tuition reimbursement
Company
CAPS® (Central Admixture Pharmacy Services, Inc.)
CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years.
Funding
Current Stage
Late StageCompany data provided by crunchbase