Quality Assurance Specialist

3 weeks ago

Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time
Job Summary

Central Admixture Pharmacy Services, Inc. is seeking a Quality Assurance Specialist - Chemistry to ensure site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications. The ideal candidate will have a minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

Key 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 Managers staff meetings.

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.

What We Offer

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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