Microbiology Quality Control Lead
2 weeks ago
Overview
B. Braun Medical Inc. is a leader in providing high-quality, same-day admixture services and solutions to healthcare facilities across the nation. With over 28 years of experience, we operate the largest network of outsourcing pharmacies, ensuring safety and compliance in all our operations.
Position Summary:
As the Microbiology Quality Control Lead, you will oversee the CAPS QC Microbiology team, ensuring that all microbiological testing and special projects align with our stringent quality standards.
Key Responsibilities:
1. Plan, coordinate, and manage the activities of the Microbiological Laboratory to meet both internal and external standards efficiently.
2. Supervise test operations for Sterility Testing, Bacterial Endotoxin Testing, and Microbiological Identification, ensuring accurate handling of laboratory results.
3. Ensure timely completion of microbiological tests according to specifications and methods, facilitating the release of pharmaceutical products and medical devices.
4. Prepare and maintain GMP/ISO procedures relevant to the laboratory operations.
5. Collaborate with production teams on projects and task forces as needed.
6. Conduct trend analysis and compile data on production deviations when necessary.
7. Participate in internal and external audits, contributing to compliance and quality assurance efforts.
8. Engage in the Global Microbiology Task Team as required.
9. Oversee microbiological release processes for medical devices and pharmaceutical products, including incoming materials.
10. Support microbiological tasks related to process validation.
11. Provide training and development for team members to enhance their skills and knowledge.
Qualifications:
Required:
- Bachelor’s degree in a relevant field; Master’s degree preferred.
- Demonstrated leadership skills and experience in educational training.
- Previous supervisory experience in a microbiological or quality control setting.
- cGMP and aseptic processing training/experience are essential.
Expertise:
Successful candidates will possess a comprehensive understanding of industry practices and procedures, utilizing standard theories and principles to propose effective solutions. The role requires independent judgment to resolve complex issues, with primary contacts being department supervisors, leads, and peers.
The compensation for this role will be determined based on various factors, including skills, experience, and organizational needs.
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