Mgr I, QC Microbiology at B. Braun Medical Inc.
Posted in Other 5 days ago.
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Location: Irvine, CaliforniaJob Description:
B. Braun Medical Inc.
Requisition ID 2018-11967
Company B. Braun Medical Inc
# of Openings 1
Job Locations US-CA-Irvine
Position Type Regular Full-Time
Shift 8am - 5pm
Site Irvine, CA
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.
Plan, organize, and manage the activities related to Quality Control Microbiology group, including Product Testing and Environmental Monitoring, to ensure timely completion of the group's tasks. Manage the development and implementation of related programs to maximize efficiencies of staff, testing, monitoring, and budgetary resources necessary to support the company goals while complying with regulatory requirements.
Responsibilities: Essential Duties
- Oversees the performance of functional group to assure that products and processes meet company and regulatory requirements.
- Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
- Interface on an as needed basis with regulatory agencies in conjunction with new drug submissions and during routine audits, field complaint investigations and technical interchanges to present the company view point.
- Implement process validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
- Directs the investigation of excursions in Manufacturing or other related operations resulting in abnormal operation rejections. Resolves nature of the cause, impact, disposition and corrective actions.
- Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
- Manage Corrective Action Preventive Action (CAPA) initiatives related to microbiology affairs for main plant.
- Reviews and approves validation protocols and reports to support change controls.
- Provides technical support to R&D and Sterilization Engineering for new product development.
- Reviews environmental data trending reports.
- Writes, revises, and approves microbiology department procedures.
- Responsible for maintaining departmental budget including leading cost savings initiatives.
Expertise: Knowledge & Skills
- Broad knowledge of scientific theories, instrumentation, and techniques.
- Thorough knowledge of GMPs, GLPs, and pharmaceutical products.
- Familiarity with requirements for submissions to regulatory agencies.
- Working knowledge of parenteral manufacturing.
- Working knowledge of all phases of company manufacturing and laboratory operations.
- 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
- Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company
Expertise: Qualifications - Experience/Training/Education/Etc
- B.A./B.S. degree in Microbiology and eight or more years of experience in a pharmaceutical or medical device company. One to three years previous managerial experience.
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.
Responsibilities: Other Duties:
- Limited domestic and/or international travel may be required
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.
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.
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.