CAPS® (Central Admixture Pharmacy Services, Inc.)
CAPS QC Coordinator
CAPS® (Central Admixture Pharmacy Services, Inc.), Phoenix, Arizona, United States, 85003
B. Braun Medical Inc. is a leader in infusion therapy and pain management, developing, manufacturing, and marketing 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.
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. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary Monday – Friday
Responsibilities: Essential Duties
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.
Expertise: Knowledge & Skills
Knowledge of pharmacy operations and regulatory guidelines.
Ability to perform pharmacy calculations.
Other duties as assigned by immediate supervisor.
Expertise: Qualifications – Experience/Training/Education/Etc 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.
Other duties as assigned by supervisor.
Desired
Minimum of 2 years experience in pharmacy preparation.
Pharmacy Technician Certification.
Physical Demands
Some travel may be required.
Ability to stand and/or sit for long periods of time.
Ability to reach, grasp, stoop, pull and perform repetitive motion procedures.
Ability to lift up to 20 lbs.
Work Environment
Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
Salary Range: $24.00 – $30.00 Hourly
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.
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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. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary Monday – Friday
Responsibilities: Essential Duties
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.
Expertise: Knowledge & Skills
Knowledge of pharmacy operations and regulatory guidelines.
Ability to perform pharmacy calculations.
Other duties as assigned by immediate supervisor.
Expertise: Qualifications – Experience/Training/Education/Etc 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.
Other duties as assigned by supervisor.
Desired
Minimum of 2 years experience in pharmacy preparation.
Pharmacy Technician Certification.
Physical Demands
Some travel may be required.
Ability to stand and/or sit for long periods of time.
Ability to reach, grasp, stoop, pull and perform repetitive motion procedures.
Ability to lift up to 20 lbs.
Work Environment
Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
Salary Range: $24.00 – $30.00 Hourly
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.
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