CAPS QC Coordinator

Company: Central Admixture Pharmacy

Job Posting

Location:

Phoenix, Arizona, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available: No

Requisition : 9247

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety.

B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the

B. Braun Group of Companies in the U.S., which includes

B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the

B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy,

B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about

B. Braun Medical, visit

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. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the

B. Braun Group of Companies in the U.S.

Ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs).

• 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

• Knowledge of pharmacy operations and regulatory guidelines.
• Ability to perform pharmacy calculations.

• 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.

• Minimum of 2 years experience in pharmacy preparation.
• Pharmacy Technician Certification.

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The…