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Microbiology Quality Control Lead

2 months ago

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


B. Braun Medical Inc., a leader in the healthcare industry, has been providing exceptional admixture services and solutions to hospitals and outpatient facilities for over 28 years.

As part of the largest 503A sterile injectable outsourcing network, B. Braun excels in batch compounding on a national scale through three 503B registered outsourcing facilities.

With extensive experience, capacity, and a commitment to safety, B. Braun is your trusted 503B partner.

Position Summary:
Accountable for overseeing the Quality Control Microbiology team to assist B. Braun pharmacies with microbiological assessments and specialized projects.

Key Responsibilities:
  1. Plan, coordinate, and manage the overall operations of the Microbiological Laboratory in accordance with internal and external standards while ensuring cost-effectiveness.
  2. Directly responsible for supervising testing operations at all times for Sterility Testing, Bacterial Endotoxin Testing, Microbiological Identification, and managing laboratory results.
  3. Ensure that all necessary microbiological tests are conducted per specifications, methods, and instructions to guarantee timely release of pharmaceutical products and medical devices.
  4. Responsible for drafting and updating GMP/ISO procedures within the area of responsibility.
  5. Engage in projects and task forces in collaboration with production staff as needed.
  6. Compile trend analyses and data on deviations in the production process when necessary.
  7. Participate in internal and external audits.
  8. Contribute to the Global Microbiology Task Team as required.
  9. Oversee microbiological release of medical devices and pharmaceutical products, as well as incoming materials.
  10. Support microbiological tasks related to process validation.
  11. Facilitate training and proactively enhance the educational standards of responsible personnel.

Required Expertise:

Possesses comprehensive knowledge of relevant business practices and procedures within the professional field. Applies standard theories, principles, and concepts to propose effective courses of action.

Operates under general supervision, relying on experience and judgment to achieve assigned objectives. May assist in orienting, training, and reviewing the work of peers.

Judgment is essential in resolving complex issues based on experience.

Interactions are primarily with department supervisors, leads, subordinates, and peers, with occasional contact with external contractors/vendors.

cGMP experience/training and Aseptic processing training/experience are required.


Qualifications:

Required:
Bachelor's degree is mandatory; a Master's degree is preferred.
Demonstrated skills and abilities in leadership and educational training will be considered.
Previous supervisory experience is essential.
cGMP experience/training and Aseptic processing training/experience are required.

PI
BA/BS/Undergraduate

0-1 Year