With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic. Responsibilities Position Summary:
Supervises the activities for the B. Braun Microbiological Laboratory. Responsible for proper oversight and development of Product Quality Control, Bioburden, Environmental Monitoring and Sterility Assurance Programs. Operates in accordance with company policies and procedures and FDA Regulations. Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Schedules and coordinates a wide variety of testing among several laboratory technicians and performs associated supervisory duties.
- Performs final review of test data/reports to ensure conformance to the established specifications and other related standard operating procedures.
- Perform, review and provide guidance to team members' performing product and process quality investigations. Evaluate product impact, determine root cause and suitable corrective actions to prevent recurrence.
- Review monitoring data for adverse trends and excursion, evaluate potential for product and process impact and determine suitable action plans (when needed).
- Reviews technical reports and other sources of information to ensure that laboratory practices are consistent with current industry and regulatory requirements. Disseminates related information and updates procedures to reflect current technology.
- Perform, review and provide guidance to team members' performing analytical instrument, software and method validations.
- Prepares protocols and technical reports for validating changes to existing products and processes such as Container Closure Integrity, Cycle Time Reduction studies or other testing as needed.
- Interfaces with Sustaining Engineering, R&D, and Sterilization Engineering regarding new or changes to existing products and processes.
- Manages project timelines and resources related to QC Microbiology support
- Assists with or prepares annual department budget.
- Proficient with Biological Indicator use such as vessel qualifications, sterilization cycle development and validation, sterility assurance.
- Proficient in BI D & z value determination..
- Proficient in Microbial Identification methodology.
- Proficient in qualifications of incoming and purchased media & reagents.
- Proficient in spore suspension preparation and enumeration.
- Review completed controlled data sheets, notebooks and validated computer spreadsheets to ensure compliance to existing specifications and standard operating procedures.
- Train laboratory technicians in all processes relevant to QC Microbiology.
- Order supplies necessary for the successful operation of the QC Microbiology laboratory.
- Self-motivated with the ability to initiate, develop, and institute new projects and special studies.
- Write and edit laboratory procedures.
- Problem solve in the laboratory.
- Other duties as assigned.
Qualifications Expertise: Qualifications - Experience/Training/Education/Etc Required:
- Computer knowledge
- Theoretical knowledge of subject matter, CGMP, FDA guidelines, ISO guidelines, GLP and USP's
- Ability to work effectively in a multi-cultural environment.
- High energy, people oriented individual with the ability to develop and to motivate subordinates.
- Good organizational skills with the ability to promote and adapt to changes.
- Excellent verbal and written communication skills are required.
- Must be able to operate independently, analyze information, and make quality decisions under pressure.
- BA/BS degree in related science.
- Minimum of 2 years of previous supervisory experience.
- Minimum of 4 years of laboratory experience associated with the testing performed in a QC Microbiology Laboratory.
- Working Knowledge and/or experience in Terminal Sterilization Manufacturing and parametric release programs
- Working Knowledge and/or experience in Equipment and Test Method Validation
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Other 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. 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. 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. The noise level in the work environment is usually moderate.