B. Braun

PFG Technician

Job Locations US-PA-Breinigsville
Requisition ID
2020-17036
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00 AM to 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:

 

The qualified candidate will perform incoming Quality inspection on Purchased Finished Goods (PFGs) to assure compliance to specified visual, physical, and supplier documentation requirements within B. Braun Medical, Inc. (BBMI) specifications, drawings, and Standard Operating Procedures (SOPs) at the Breinigsville Distribution Center.  Candidate will be responsible for documenting results, reviewing other inspectors’ data, and releasing PFGs within the SAP ERP.  Candidate will be required to make quality decisions in relation to PFG acceptability and disposition PFGs accordingly.  Candidate will initiate Discrepancy Notifications (DNs), Supplier Corrective Action Notifications (SCANs), and Intercompany Complaints (ICs) in accordance with site and corporate procedures for nonconforming incoming PFGs.  Candidate will process, and coordinate timely closure of, PFG complaints with affiliate and non-affiliate suppliers for post-market issues in accordance with site and corporate procedures.  This includes handling, processing, and shipping customers’ samples to the appropriate supplier site.  Candidate will interface with site, corporate, and international B. Braun colleagues as well as domestic and international suppliers.   Candidate will also track and report metrics, operate in accordance with company policies, and perform other duties as assigned by department management.

 

Responsibilities: Essential Duties

  • Assures incoming PFGs comply to specified visual, physical, and supplier documentation requirements within B. Braun Medical, Inc. (BBMI) specifications, drawings, and Standard Operating Procedures (SOPs).
  • Executes the following incoming PFG inspection activities to support timely PFG release to warehouse inventory to ensure business continuity:
    • Inspect incoming PFGs as stated above
    • Document inspection results and upload Certificates of Compliance and/or Certificates of Analysis into SAP
    • Review inspection results and uploaded Certificates of Compliance and/or Certificate of Analysis from other inspectors for completeness and accuracy.
    • Release conforming PFGs electronically to warehouse inventory
  • Communicates quality related issues to senior inspectors and/or Quality Management for awareness and resolution.
  • Initiates Discrepancy Notifications (DNs) within SAP for nonconforming incoming PFGs in accordance with corporate and site procedures.
  • Initiates, issues, and coordinates timely completion of Supplier Corrective Action Notifications (SCANs) and Intercompany Complaints (ICs) for nonconforming incoming PFGs in accordance with corporate and site procedures.  Also, supports administrative aspects of responses received from affiliate and non-affiliate suppliers.
  • Rework, reprocess, resample, and/or reinspect nonconforming PFGs to bring into conformance, or verify conformance to specifications and drawings.
  • Documents data and/or information in accordance with corporate Good Documentation Practices (GDPs) requirements.
  • Processes, and coordinates timely closure of, PFG complaints with affiliate and non-affiliate suppliers for post-market issues in accordance with corporate and site procedures.  Handles, processes, and ships samples, obtained from customers, to the applicable supplier site for investigation.   Communicates with supplier representative for status of investigations, corrections, corrective actions, and closure.
  • Interfaces, and communicates professionally and effectively with all departments as needed to address and resolve any PFG related issues.
  • Collaborates with the PFG Team, and contributes ideas and provides suggestions, for continuous quality improvements.
  • Ensure training is completed on-time to meet target training metrics.
  • Reflects in performance and attitude the company’s strong support of Quality.
  • The Essential Duties listed are not exhaustive and shall also include any responsibilities as assigned by department management as required.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
 

Expertise: Knowledge & Skills

  • Requires working knowledge of technical field/area of specialization. Exercises general application of principles, theories and concepts. Follows established procedures and guidelines.
  • Works under general supervision. May periodically assist in orienting, training, assigning & checking the work of other peers.
  • May require some limited judgement in resolving problems.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
  • Knowledgeable of quality policies, FDA Regulations and ISO Standards for medical devices or pharmaceutical operations.   
  • Knowledgeable of inspection techniques, procedures tools, materials and/or equipment.
  • Good verbal and written communication skills through various modes of communication, e.g., face-to-face, email, IM, telephone, videoconference, etc.
  • Strong attention to detail and accurate record keeping. 
  • Strong decision-making and problem-solving skills.
  • Ability to perform effectively in a team environment to resolve problems
  • Basic computer skills including a word processing, and spreadsheet / data tracking analysis.
  • Must be flexible and able to adapt to changes in priorities, including working earlier and later than scheduled shift start, and working overtime, when necessary.

Work Environment:

 

The main work environment is an office setting.  However; the candidate will be expected to perform essential duties within a warehouse and laboratory setting.  Proper Personal Protective Equipment (PPE) will be required, e.g., steel toe shoes, high visibility clothing, safety glasses, lab coats, gloves, etc.  Special consideration will also be applied to the warehouse for awareness to continuous Powered Industrial Truck (PIT) traffic and sample handling area, where universal precautions must be adhered to for complaint samples that are returned from customers.  All areas are temperature monitored and controlled, where specified, for product requirements, and personnel comfortability.   

Preferred:

  • 02 – 04 years of related Quality experience required.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.
  • 02-04 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable on-site attendance
  • Ability to work non-standard schedule as needed

 

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

Activities:

  • Occasionally:
  • Frequently:N/A
  • Constantly:N/A

Environmental Conditions:

  • Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
  • 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:N/A
  • Frequently:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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