Quality Assurance Specialist

4 days ago

Allentown, Pennsylvania, United States B. Braun Medical Inc Full time

Job Title: Quality Technician

Job Summary:

We are seeking a highly skilled Quality Technician to join our team at B. Braun Medical Inc. The successful candidate will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) and specifications.

Key Responsibilities:

  • Perform product inspection for defects, leaks, and particulates.
  • Perform environmental monitoring of personnel and complete documentation.
  • Assist in the media fill process validations, including 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, and 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 and 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.
  • Desired: Experienced in aseptic operations, experience within a regulated environment, and 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.

Equal Opportunity Employer:

B. Braun is an Equal Opportunity Employer and welcomes applications from diverse candidates.

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