Job Description Summary

This position is responsible to lead investigations resulting from customer complaints, Quality Notifications, audit findings, and other sources as required by using structured root cause analysis and problem-solving techniques. Interact professionally with internal associates, associates from other BD manufacturing plants, suppliers, Regional Quality Units, and WW Quality Units to support resolution of customer quality issues. Use investigation results to continually assess the adequacy of process and systems, issuing corrective actions as required to maintain an effective quality system. Supports the quality of material and product by verifying standard operating procedures (SOP’s), product specifications and Good Manufacturing Practices (GMP). Ensures compliance with BD quality systems, policies, procedures, and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

1st shift – Monday-Friday 8:00AM-5:00PM

JG3

PCP Level 1

Responsibilities include but are not limited to:

1. Investigation, prioritization, and timely response for customer complaints.

2. Assess the complaint vs. established quality criteria. Determine the investigation path (valid vs. information).

3. Effectively communicate findings thru technically written, data focused reports.

4. Thoroughly investigate the non-conformance, driving to a root cause and robust corrective and preventative actions.

5. Review batch records, change control, validation, Quality Notification trends, and other data sources as required as part of the investigation process.

6. Work with the other Customer Quality Specialists to ensure all complaints are being investigated and timelines for the investigation are consistently met.

7. When applicable coordinate and lead the correct “team” to investigate higher priority complaints.  

8. Prepare and communicate recommendations for improvement of both processes and systems based on investigation results.  

9. Understand and be proficient in the CAPA system.

10. Perform trend analysis of customer complaints.

11. Update procedures as necessary.

12. Track and trend Quality Notifications

13. Support the month end Quality reporting (local and WW Quality metrics).

14. Assist NS (non-sterile) batch release on an “as need” basis.

15. Assist or lead Engineering Studies / Special Test Requests.

16. Project work, coaching and leading of work related to Quality Investigations and Customer complaints.

17. Support the internal audit program.

18. Other duties as required to support the needs of the business.

• On time customer response to complaints and general inquiries

• Timely and accurate communications/updates to Quality supervision and site’s functional groups regarding any quality issues, specifically around customer complaints / Quality Notifications.

• Responsible to monitor that materials and product consistently meet Customer and Quality specifications.

• Understand the reporting of and compliance to Worldwide defined metrics

• Ability to learn and author SA’s (Situational Analysis) reports when required.

Supervision:

• This position does not supervise any associates at any level

Education and Experience

Minimum Education :

• Required :  HSD/GED

• Preferred :  BA/BS – Engineering or other relevant field

Minimum Experience :

• 1-3 years GMP experience

• Pharmaceutical/medical device experience preferred

• 1–3 years’ experience with root cause investigation tools.

• 1-3 years working with within a “team environment”