CAPS Quality Technician - Microbiology

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Company: Central Admixture Pharmacy
Job Posting Location: Phoenix, Arizona, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Wednesday, Friday, Thursday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition : 3944

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.

Position Summary:
Monday-Friday, 6:30am-3pm (1st Shift)

Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

Essential Duties/Responsibilities:

• Perform product inspection for defects, leaks and particulates.
• Perform environmental monitoring of personnel (as needed) and complete documentation.
• Assist in the media fill process validations to include inspection of filled units
• Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
  • Verify that raw materials meet specification
  • Verify and account for labeling
  • Review temperature and BMS alarms
  • Verify that product test results meet specification limits
  • Verify that all documentation is complete
  • Document non-compliance and work with supervisor/lead if further investigation is needed
• Submit samples to the appropriate lab for particulate identification or microbial analysis.
• Assist with equipment calibration program and maintenance record files.
• Assist with raw material release and movement.
• Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
• 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 Quality Manager’s staff meetings

Expertise:
Knowledge & Skills

• Knowledge of pharmacy operations and regulatory guidelines.
• Ability to perform calculations.
• Ability to work within established procedures and practices
• Strong organizational skills and attention to detail
• Ability to effectively troubleshoot issues.

Qualifications - Experience/Training/Education/Certification/Etc:

Required:

• Minimum of High School Diploma/GED with work experience
• Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

• Desired:

• Experienced in aseptic operations.
• Experience with in a regulated environment
• Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.

• While performing the duties of this job, the employee is regularly required to…