B. Braun

Supplier Auditing Specialist

Job Locations US-PA-Allentown
Requisition ID
2021-18121
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00 AM - 4:30 PM
Site
Allentown, PA

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 administering and oversight of the BBMI supplier audit program to support operations in accordance with all BBMI process and procedures and regulatory requirements ensuring timely, effective audit service and delivery that satisfies internal customers and regulatory compliance requirements.  The Supplier Auditing Specialist has working knowledge of industry best practices and standards for quality related compliance issues and solutions to system effectiveness, as well as working knowledge of with cGxPs as well as ISO, ICH and USPs and applicable regulations.

 

Responsibilities: Essential Duties

  •  Develops annual supplier audit schedules in conjunction with site leadership and procurement.
  •  Monitors performance to schedule, report on schedule attainment and work with site leadership to meet the audit schedule.
  •  Ensures that the supplier audit program and associated procedures and forms meet regulatory compliance requirements and are aligned with industry best practices
  •  Perform supplier and internal quality system audits including execute and prepare audit report on a timely basis.
  •  Maintains files generated from each audit.
  •  Performs necessary Follow up which include communicating with auditee(s) on status of action resolution.
  • Supports management reviews in the preparation and communication of quarterly and annual compliance metrics and summaries for distribution to management.
  • Identify and communicate systemic compliance issues to management for further comprehensive action. Leads efforts to remediate issues and ensures effective resolution.
  • Provides internal communication regarding compliance issues discovered and trended through supplier audits and applicable regulation changes and escalate as needed.
  • Provides input and creation of gap analysis to any new/changed regulations.
  • Provide support to BBMI sites during regulatory audits and inspections.
  • Maintains comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation. Provides regulatory compliance expertise to the divisions & sites by sharing external regulatory environment and industry trends.
  • Has working knowledge of industry best practices and standards for quality related compliance issues and solutions to system effectiveness. Maintain current with best practices in quality and compliance practices within the industry and provide some overall translations of system effectiveness during supplier audits.
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 advanced knowledge of professional field and industry.
  • Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals.
  • May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers.
  • Occasional contact with external contractors/vendors.
  • Experience with quality assurance standards such as ISO, ICH, USP & GxP is preferred.
  • Data analysis; Understanding of informatics and analytics of quality systems
  • Statistical sampling methods
  • CGMP’s, QSR’s, ISO, CMDR, and MDD
  • Risk Management techniques
  • Knowledge of budgeting principles and general administrative practices

 

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required, Master's degree preferred.
  • 08-10 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable attendance
  • Frequent business travel required

 

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, Stand
  • Frequently:Sit
  • Constantly:N/A

Activities:

  • Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
  • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , 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:Other
  • Frequently:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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