B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities: Essential Duties
Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.
Directly responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS result.
Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.
Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.
Participates in projects, task force jointly with production personnel in case the needs arise.
Prepares trend analysis and data compilation on deviation in the production process when required.
Participates in internal and external audit.
Participates in the Global Microbiology Task Team, whenever required.
Responsible in microbiological release of medical devices or Pharma products and Pharma incoming materials.
Supports microbiological tasks for process validation.
Trains and proactively develops the education standard of the responsible persons.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Expertise: Knowledge & Skills
Requires basic knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
Some degree of judgment required in resolving problems based on experience.
Contacts are primarily with direct supervisor, peers and subordinates.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
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