Microbiology Quality Control Lead
2 weeks ago
B. Braun Medical Inc. is a leader in the healthcare industry, providing exceptional outsourcing admixture services and solutions to hospitals and outpatient facilities for over 28 years.
As part of the largest 503A sterile injectable outsourcing network in the nation, we also offer top-tier batch compounding through our three 503B registered outsourcing facilities.
With extensive experience, capacity, and a commitment to safety, B. Braun is your trusted 503B partner.Position Summary:
In this role, you will lead the Quality Control Microbiology team to support our pharmacies with microbiological testing and specialized projects.
Key Responsibilities:
1. Plan, coordinate, and organize the activities of the Microbiological Laboratory in compliance with internal and external standards, ensuring cost-effectiveness.
2. Supervise test operations for Sterility Testing, Bacterial Endotoxin Testing, and Microbiological Identification, ensuring accurate handling of laboratory results.
3. Ensure timely completion of necessary microbiological tests according to specifications and methods, facilitating the release of pharmaceutical products and medical devices.
4. Prepare and update GMP/ISO procedures relevant to your area of responsibility.
5. Collaborate on projects and task forces with production personnel as needed.
6. Conduct trend analysis and compile data on production deviations when required.
7. Participate in internal and external audits.
8. Engage in the Global Microbiology Task Team as necessary.
9. Oversee microbiological release of medical devices, pharmaceutical products, and incoming materials.
10. Support microbiological tasks for process validation.
11. Train and develop the educational standards of responsible personnel.
Expertise:
Knowledge & Skills:
This position requires a comprehensive understanding of relevant business practices and procedures within the professional field. You will utilize standard theories, principles, and concepts to propose effective courses of action.
Work will be conducted under general supervision, relying on your experience and judgment to achieve assigned goals. You may assist in orienting, training, and reviewing the work of peers.
Judgment is essential for resolving complex issues based on your experience.
Primary contacts will include department supervisors, leads, subordinates, and peers, with occasional interactions with external contractors or vendors.
cGMP experience and aseptic processing training are required.
Qualifications:
Required:
1. Bachelor's degree required; Master's degree preferred.
2. Proven skills in leadership and educational training will be considered.
3. Previous supervisory experience is essential.
4. cGMP experience and aseptic processing training are mandatory.
PI
BA/BS/Undergraduate
0-1 Year
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