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Microbiology Quality Control Specialist

2 months ago

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


B. Braun Medical Inc. is a leader in providing high-quality outsourcing admixture services and solutions to healthcare facilities across the nation. With over 28 years of experience, we pride ourselves on delivering same-day services that meet the highest standards of safety and efficacy.

As part of the B. Braun Group, we operate the largest 503A sterile injectable outsourcing network and offer industry-leading batch compounding through our three 503B registered facilities.


Position Summary:
In this role, you will oversee the CAPS Quality Control Microbiology team, ensuring that microbiological testing and special projects are conducted efficiently and accurately.
Key Responsibilities:
  • Plan, coordinate, and manage the activities of the Microbiological Laboratory in compliance with internal and external standards while optimizing costs.
  • Supervise testing operations for Sterility Testing, Bacterial Endotoxin Testing, and Microbiological Identification, ensuring accurate handling of laboratory results.
  • Guarantee that microbiological tests are performed according to established specifications and methods, facilitating timely product releases.
  • Prepare and maintain GMP/ISO procedures relevant to your area of responsibility.
  • Engage in collaborative projects with production teams as needed.
  • Conduct trend analysis and compile data on production deviations when necessary.
  • Participate in internal and external audits, contributing to the Global Microbiology Task Team as required.
  • Oversee microbiological release processes for medical devices and pharmaceutical products.
  • Support microbiological tasks related to process validation.
  • Provide training and development for team members to enhance their expertise.

Qualifications:
  • Bachelor's degree required; Master's degree preferred.
  • Demonstrated leadership skills and experience in educational training.
  • Previous supervisory experience is essential.
  • cGMP and aseptic processing training/experience are required.

We value the skills and experiences that each candidate brings to our organization and consider a range of factors when making compensation decisions. This includes skills, experience, training, and other organizational needs.