Sr Microbiology Specialist - United States
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Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 175 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 55,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.
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.
- 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
- Schedule and coordinate a wide variety of testing among several laboratory technicians and perform associated duties
- Perform final review of test data/reports to ensure conformance to the established specifications and other related standard operating procedures.
- Investigate alert and action level excursions as well as process deviations in order to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature.
- Review technical reports and other sources of information to ensure that laboratory practices are consistent with current industry and regulatory requirements. Disseminate related information and update procedures to reflect current technology.
- Provide technical information and support to other disciplines to assure that company products and processes conform to regulatory and industry requirements.
- Prepare protocols and technical reports for validating new product/process development and changes to existing products/processes.
- Evaluate technical problems and provide recommendations for corrective actions.
- Write, collect, organize and compile data and reports to provide information for use by upper management or to comply with regulatory requirements.
- Interface with a wide variety of disciplines to evaluate applicability of existing methods.
- Assist manager in department budget preparation.
- Design, conduct and evaluate scientific studies to develop and/or validate test methods for use by the applicable functional group.
- Review and/or develop specifications for new components and products for suitability with manufacturing systems.
- Investigate and resolve customer complaints related with product quality/performance.
- Evaluate, specify and justify major capital requirements.
- Implement, validate and train personnel in new laboratory instrumentation and methods. Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
- Establish investigation and re-start protocols to support product/sub-component disposition utilizing appropriate statistical sampling plan.
- Provide risk assessment on product nonconformance and field performance issues.
- Establish process control limits utilizing Statistical Process Control (SPC)
- Support Corrective Action Preventive Action (CAPA) projects and investigation of root cause for Product Investigation Report (PIR).
- Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports.
- Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.
- Interface with Engineering, Manufacturing, Regulatory Affairs, Research & Development, and other technical disciplines to represent QA in project teams, with the objective to assure that project quality objectives are met.
- Represent company in contacts with regulatory agencies, including interface with FDA inspectors
- Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
- Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.
- Expertise: Knowledge & Skills
- Computer knowledge
- Statistics and measurement theory.
- Knowledge of GMPs, GLPs and environmental regulations
- Laboratory instruments.
- Excellent verbal and written communication skills.
- Good analytical skills.
- Interpersonal skills.
- Ability to meet deadlines.
- Good organizational skills.
- Must be able to work independently.
- Expertise: Qualifications - Experience/Training/Education/Etc
- BS/BS degree in related science.
- 8-10 years of technical experience in the pharmaceutical or medical device industry.
- 5 or more years experience in QA/QC organizations.
- 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.
What we offer
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.
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.