Quality Assurance Specialist

1 day ago


Phoenix, Arizona, United States B. Braun Medical Inc Full time
Job Title: Quality Technician

Join B. Braun Medical Inc. as a Quality Technician and contribute to the success of our Central Admixture Pharmacy Services (CAPS) team.

About CAPS

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 over 28 years.

As a leading provider of 503A sterile injectable outsourcing services, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities.

Responsibilities
  • Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications.
  • Perform quality review of documents, label control, assist with release activities and product inspections.
  • 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.
Requirements
  • 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.
  • Experienced in aseptic operations.
  • Experience within a regulated environment.
  • Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.
What We Offer

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the web.

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



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