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.
JG2

JOB SUMMARY

Manage the final release of product to sterilization. Ensure Quality Inspection (QI) Stock level are maintained to meet business needs. 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 Responsibilities (Primary Duties, Roles, and/or Authorities)

Responsibilities include but are not limited to:

• Verify the created Lot Packet(s)/Batch Record(s) are complete and organized properly with all associated forms to allow completion of the Audit Trail.
• Identify and track Good Documentation Practice (GDP) deficiencies (i.e. flags) and provide guidance for proper resolution.
• Confirm the accuracy of goods issued to batches by generating a Goods Issued report and comparing it to relevant information in the lot packet/batch record.
• Perform the final review of lot packet(s)/batch record(s) as assigned, review and approve all applicable inspection forms, assuring that all records, upstream tests, TWIs, and Quality Notifications (QN) required for the batch are present, complete, and accurate.
• Compile data and prepare testing reports as required through the use of Minitab and/or Excel. Initiate applicable QNs and investigations.
• Close applicable QNs. Perform SAP and MES transactions. (i.e.: Results Recording, Usage decision, Stock Movements, Hold/Release LP) Approve release of completed lot packet(s)/batch record(s). Provide product/document tracking and maintain a record of reviewed and completed lot packet(s)/batch record(s).
• Archives Lot Packets. Other duties as required to support the needs of the business.
• Timely product release to support manufacturing objectives.
• Accurate enforcement of cGMP and GDP guidelines.

MINIMUM EDUCATION :

Required : HSD/GED
Preferred : Associates degree – Quality Assurance or related field

MINIMUM EXPERIENCE:

• 2-3 years of manufacturing experience (medical device preferred).
• Final inspection experience and reviewing quality data preferred.

• Verify the created Lot Packet(s)/Batch Record(s) are complete and organized properly with all associated forms to allow completion of the Audit Trail.
• Identify and track Good Documentation Practice (GDP) deficiencies (i.e. flags) and provide guidance for proper resolution.
• Confirm the accuracy of goods issued to batches by generating a Goods Issued report and comparing it to relevant information in the lot packet/batch record.
• Perform the final review of lot packet(s)/batch record(s) as assigned, review and approve all applicable inspection forms, assuring that all records, upstream tests, TWIs, and Quality Notifications (QN) required for the batch are present, complete, and accurate.
• Compile data and prepare testing reports as required through the use of Minitab and/or Excel. Initiate applicable QNs and investigations.
• Close applicable QNs. Perform SAP and MES transactions. (i.e.: Results Recording, Usage decision, Stock Movements, Hold/Release LP) Approve release of completed lot packet(s)/batch record(s). Provide product/document tracking and maintain a record of reviewed and completed lot packet(s)/batch record(s).
• Archives Lot Packets. Other duties as required to support the needs of the business.
• Timely product release to support manufacturing objectives.
• Accurate enforcement of cGMP and GDP guidelines