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Aseptic Quality Assurance Specialist
1 month ago
Aseptic Quality Assurance Specialist
About Us
B. Braun Medical Inc., a leading provider of infusion therapy and pain management solutions, is dedicated to developing innovative medical products and services that improve patient outcomes and clinician satisfaction. Our company is committed to eliminating preventable treatment errors and enhancing patient, clinician, and environmental safety.
Job Summary
We are seeking an experienced Aseptic Quality Assurance Specialist to join our team at Central Admixture Pharmacy Services, Inc. in Allentown, PA. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality and safety in our aseptic processes and facilities.
Key Responsibilities
The successful candidate will have the following responsibilities:
- Conduct daily visual audits of aseptic behavior inside the cleanroom during setup, filling, teardown, and sanitization processes;
- Communicate openly with all personnel in the cleanroom to provide real-time feedback and mentoring on observed aseptic performance;
- Take immediate corrective and preventative action when non-compliance and/or undesired behavior by personnel in the facility is observed;
- Provide corrective action training based on visual audits by providing immediate feedback;
- Partner with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic processes and completion of required trainings;
- Review aseptic technique associated with media fills and help complete documentation and final vial count verification as necessary;
- Perform other essential quality functions including, but not limited to: release of cleaning agents, release of raw materials, and line clearance;
- Responsible for training personnel in Aseptic Techniques and processes.
Requirements
To be successful in this role, the ideal candidate will have the following qualifications:
- Bachelor's degree required;
- 04-06 years related experience required;
- cGMP experience/training required, Aseptic processing training/experience required;
- Strong understanding of aseptic techniques and practices;
- Excellent communication and interpersonal skills;
- Ability to work effectively in a fast-paced environment.
Benefits
We offer a competitive salary range of $63,400 - $79,520 per year, depending on experience, along with a comprehensive benefits package that includes health insurance, 401(k) plan, and tuition reimbursement. If you are a motivated and detail-oriented individual who is passionate about quality and safety, we encourage you to apply for this exciting opportunity.