Manager III, Quality Control (Microbiology)

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 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

• Manages the quality control activities of an organization.
• Assists with overseeing tasks associated with inspecting and testing products.
• Ensures that products or services meet quality standards and develops corrective action when needed.
• Develops, implements and assesses processes and policies designed to test products and services.
• Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
• Enforces regulatory compliance.
• Conducts visual and physical inspections of company products and materials.
• Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.General: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

• 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.
• Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
• Experience working in a Pharmaceutical environment preferred.

Target Based Range

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• 10-12 years related experience required.
• Regular and predictable attendance
• Occasional business travel required, Valid driver's license and passport

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.

#ID

#LI

#MSL

Additional Information

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:

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
• Frequently:Stand, Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward
• Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick
• 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:Moderate
• Occasionally:Warehouse environment
• Frequently:Office environment, Production/manufacturing environment, Lab environment
• Constantly:N/A

Referral Amount

Notices

Equal Opportunity Employer Veterans/Disabled