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Senior II, QC Microbiology Specialist

Company: B. Braun
Location: Irvine
Posted on: September 15, 2020

Job Description:

Overview About B. Braun 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 61,000 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 Position Summary: Responsible for providing technical expertise and guidance for all activities associated with QC Microbiology and QC Sterilization to support manufacturing and laboratory operational efficiency and compliance while performing routine and non-routine tasks. 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. Direct 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 breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes. Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues. Judgement is required in resolving complex problems based on experience. Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors. Qualifications Expertise: Qualifications - Experience/Training/Education/Etc Required: Bachelor's degree required, Master's degree preferred. 08-10 years related experience required. Occasional business travel required. Regular and predictable attendance. Desired: 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. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its "Sharing Expertise--" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Other Responsibilities: Other Duties: Other duties as assigned. The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is expected to: Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Lifting, Carrying, Pushing, Pulling and Reaching: Occasionally:Reaching upward and downward, Push/pull, Stand Frequently: Sit Constantly: N/A Activities: Occasionally: Push/pull, Reaching upward and downward, Standing, Talking - ordinary, loud/quick, Walking Frequently: Sitting Constantly: N/A Environmental Conditions: Occasionally: N/A Frequently: N/A Constantly: N/A Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise Intensity: Low Occasionally: Production/manufacturing environment Frequently: Lab environment Constantly: Office environment Notices Equal Opportunity Employer Veterans/Disabled

Keywords: B. Braun, Irvine , Senior II, QC Microbiology Specialist, Other , Irvine, California

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