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.
Responsible for day to day quality control operations of the Finished Product Testing Microbiology Laboratory for a parenteral manufacturer of IV products. Leads a team of 4-5 direct reports and 30 indirect reports to ensure a safe, efficient working department for microbiology personnel. Critical release parameters include Bioburden, sub-visible Liquid Particulate Matter, Bacterial Endotoxin, and Sterility testing. Responsible for OOS and discrepancy investigations including determination of product impact and lot disposition related to discrepancies. Ensures all investigations are completed within the required timeline. Must have broad knowledge of microbiology as it relates to a manufacturing facility including basic knowledge of contamination sources and organism habitats. Occasionally participates in risk assessments related to product or process impact. Responsible for review of change control initiatives and / or CAPAs that impact microbiology lab functions and facility operations. Participates in continuous improvement activities to support the microbiology department or support contamination control strategies for the facility. Responsible for writing, reviewing, and approving documents to support the microbiology department and facility / manufacturing operations. This includes (but is not limited to) SOPs, annual product reports, validation documents, root cause analyses, quality protocols, trend reports, and invoice reconciliation. Key participant in new product launch planning and microbiological support testing for R&D method and product development. Supports corporate compliance initiatives to ensure that all test methods reflect current USP / FDA / other regulatory requirements and guidelines as needed. Ensures on time testing to meet supply chain demands and works with other functional area leaders on prioritization of product testing to meet customer needs. Participates in customer, internal, and regulatory audits as needed and works with leadership on audit responses and remediation activities. Ensures on time training compliance for the department. Provides training and guidance to the department for both routine operations and special projects. Ensures laboratory equipment calibrations / qualifications are done on time. Basic understanding of operational excellence strategies (i.e. 5S, GEMBA walks, time sequence studies) is helpful. SAP and LIMS experience is a plus. Enhances employee engagement by providing feedback and coordinates recognition activities.
Responsibilities: Essential Duties
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons."
Expertise: Knowledge & Skills
Expertise: Qualifications -Education/Experience/Training/Etc
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.
B. 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.
Responsibilities: Other Duties:
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.
While performing the duties of this job, the employee is expected to:
Lifting, Carrying, Pushing, Pulling and Reaching:
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.
Equal Opportunity Employer Veterans/Disabled