Prod Incident Rpt Tech I

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 www.bbraunusa.com

Position Summary:

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.

Responsibilities: Essential Duties

• 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.

Expertise: Knowledge & Skills

• 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.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Associates Degree or a Bachelor's Degree in related field
• Hepatitis B immunization
• Antibiotic and respiratory screening for Duplex plant

Desired:

• Experience in the biotech or pharmaceutical industry

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.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Responsibilities: Other Duties:

• Other duties as assigned.

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.

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. The noise level in the work environment is usually moderate.

Salary Range: $24-$26/hr

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The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.