B. Braun

Supervisor II, QC Microbiology Technical Services

Job Locations US-CA-Irvine
Requisition ID
2020-17246
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Monday - Friday; 8:00am - 5:00pm
Site
Irvine, CA

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 coordinating laboratory personnel and all activities associated with the functional area to ensure that the laboratory operates efficiently and effectively while performing routine and non-routine tasks.

 

Responsibilities: Essential Duties

  • Supervises employees, tasks and duties related to quality control within organization.
  • Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
  • Provide support to Pharma R&D and Regulatory Affairs on new product development and regulatory submissions. As necessary, assist in authoring sections for regulatory submissions or responses to regulatory submission inquiries from Regulatory Authorities.        
  • Oversee qualification/verification and routine maintenance of test methods and instrumentation used in the microbiology laboratories including supporting documentation, procedures, protocols and reports. Conduct assessments of changes to GMP and GXP systems.
  • Support internal and external audits, including Regulatory Authority inspections. Interact with Regulatory Authorities to resolve inquiries and collaborate with other site functions to satisfactorily resolve regulatory issues.
  • Monitors the performance of the quality control staff and responsible for personnel actions including (but not limited to) hiring, performance management and termination.

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

 

Expertise: Knowledge & Skills

  • Strong technical skills, ability to apply critical thinking
  • Knowledge with terminal sterilization (BI/Bioburden approach) and microbiology method validation (USP 55, 61, 71, 85)
  • Great background in new laboratory equipment validation or existing equipment requalification
  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
  • Demonstrated capabilities in effectively managing competing priorities.

Expertise: Qualifications - Experience/Training/Education/Etc

 

Preferred Qualifications: Knowledge with calculations in D-value, SAL and sterilization cycle development (CTR).

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Bachelor's degree required or equivalent combination or education and experience.
  • 04-06 years related experience required.
  • Regular and predictable attendance.

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.

Other

R

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.

 

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

Activities:

  • Occasionally: Handling, Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral
  • Frequently: Sitting , Standing, Talking - ordinary, loud/quick, Walking
  • 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: Low
  • Occasionally: Production/manufacturing environment
  • Frequently: N/A
  • Constantly: Lab environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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