B. Braun

Supervisor III, QA Product Release

Job Locations US-CA-Irvine
Requisition ID
2020-17209
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
M-F; 8am - 5pm
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:

The QA Supervisor; has the primary responsibility for supporting batch record review, Change control submission and implementation, Investigations, including but not limited to Non-conformances, CAPA’s, internal audit observations. Serve as subject matter expert in Batch Record Review and product release. The QA Supervisor has oversight of the Batch Record and Product Release team and will oversee and execute the daily, short term and long term activities and goals associated with the release of a batch. This individual will work with Quality Operations, Facilities, Mantainaces, Manufacturing, document control, and other departments to ensure cGMP compliance, meet company production Goals, provide opportunities for training and growth for employees, and ensure the optimization of safety, production, quality, and results.

 

Responsibilities: Essential Duties

  • Supervises workers and tasks within the quality assurance Product Release function of the organization.
  • Develops, implements and assesses process and policies designed to execute batch record documentation review and product release.
  • Monitors and evaluates current practices, making recommendations for improvements when necessary.
  • Enforces regulatory compliance.
  • Conducts timely quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
  • Review records to ensure data meets industry requirements for data integrity.
  • Monitors the performance of the QA Product Release staff, ensuring that the department meets organizational objectives.
  • Responsible for leading the team in completion of a routine and non-routine tasks including writing investigation reports, deviations, protocols, updating procedures and other related documentation.
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

  • 2 - 4 years of leadership and/or supervisory experience preferred.
  • 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 indirect 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.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

 

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required.
  • 06-08 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

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, 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:Lab environment
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

 

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