Prod Incident Rpt Tech

B. Braun Medical, Inc.

Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting

Location:

Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition : 9727

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 64,000 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

Coordinate the receipt and evaluation of product complaint samples. Entry of customer complaints into the PIR database. Maintain QA complaint files. Purchase supplies and maintain mail accounts. Perform initial sample evaluation and coordinate investigation of root cause for PIRs. Follow up on evaluation status and prepare a weekly status report. Draft customer response letters for all products. Ability to retrieve information on customer orders, product stock and part number traces in SAP.

Identify potential Adverse Drug Experiences and Medical Device Reports and take appropriate action. Perform basic analyst duties in the absence of the analyst.

• Receive product complaints and samples from such sources as customers, sales representatives, distributors and FDA. Enter complaints into the computerized Product Incident Report (PIR) database (access/informix database) to ensure their traceability.
• Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
• Unpack, identify and organize returned complaint samples and assist in performing initial inspection of such samples. The incumbent must follow the guidelines for handling of human blood and other body fluids with all samples in order to avoid risk of contamination. Forward samples to Purchased Finished Good manufacturers or PA also as applicable.
• Maintain the QA complaint master files, ensuring all complaint files are present and that complete information is recorded for each complaint. Include storage of files on and off site.
• Determination of routing for complaint samples to different functional areas in the plant for investigation.
• Track the receipt of complaint samples and notify the QA Analyst of samples that are overdue.
• Purchase supplies required for safe handling of complaint samples and any supplies necessary for maintenance of files, laboratory equipment, etc. Also maintain accounts at the Post Office.
• Coordinate investigation of root cause analysis for complaints with Business Units or other areas as required.
• Prepare draft response letters for all complaints with review by the Analyst.
• Prepare weekly PIR summary running access queries and tracking data in Excel spreadsheet. Graph data. Also run or create access reports to pull requested data from PIR database.
• Run SAP searches for customer order histories, available stock of product and backwards and forward part number traces as required.
• Coordinate outside PIR lab activities and follow up for investigations.
• Identify potential Adverse Drug Experiences and Medical Device Reports as PIRs are received and notify QA Analyst or QA Manager. Assist in preparation of MDR reports for submission to FDA.
• Identify any trends on incoming reports or investigation results and notify QA Analyst or QA Manager.

• Thorough knowledge of the proper handling skills for potentially infectious samples is required.
• Understanding of documentation procedures and GMPs for the health care industry.
• Thorough knowledge of medical/pharmaceutical products.
• Good understanding of CFRs for ADEs and MDRs.
• Proficiency with computers (Access, Word, Excel).
• Ability to perform general physical tests on returned samples.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Demonstration of good decision making skills.
• Ability to identify trends in reports or investigation results.
• Ability to complete tasks within a specific time frame.
• Ability to be self motivated and work independently.
• Detail oriented.

• Associate’s Degree or a Bachelor's Degree in related field
• Hepatitis B immunization
• Antibiotic and respiratory…