Associate Quality Account Mgr

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Summary of Objective:
Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Updates Batch Record Documentation and Material Specifications to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive working relationship with internal and external customers.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

1. Primary reviewer for master batch records, forms and specifications to ensure that the documents meet
internal and customer requirements for standards, procedures and requirements.
2. Assist with creating and updating batch records, forms and material specifications as well as organizing
internal and customer approval of batch records and specifications.
3. Assist with performing record reviews of completed orders and orders in process to ensure compliance with
cGMP’s and customer requirements. Assist as company liaison with customers concerning quality control
documentation. Help identify, communicate, track and resolve document related issues with other
departments and customers.
4. Performs finished product batch release of approved production lots.
5. Attend conference calls and customer meetings; provide complaint and quality related information.
6. Assist in the preparation of annual product review data.
7. Assist with generating and presenting quality related metrics and key performance indicators for team’s
performance.
8. Assist with the investigation of Quality deviations and the drafting of investigation reports associated with
such deviations.
9. Assist with addressing and documenting quality events with Production and Quality teams.
10. Assist with training, developing, and mentoring new Quality Coordinators.
11. This position may require overtime and/or weekend work.
12. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
13. Attendance to work is an essential function of this position
14. Performs other duties as assigned by Manager/Supervisor.
15. Develop, update and implement procedural changes throughout the organization.
16. Standardize documentation to ensure PCI’s Standard for Quality is achieved throughout our customer base.
17. Coach, train, mentor and develop PCI’s employees to ensure Quality Standards are met and maintained.
18. Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material
Specifications, Forms, Work Practices and Standard Operating Procedures.
19. Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint
Samples or Rework as needed to support the various groups throughout PCI.
20. Compile, update and analyze customer / internal data and metrics to identify potential trends and areas for
opportunities. Utilize the Microsoft Office Suite in detail to present data / facts in a professional fashion.
21. Assist and Support the RIT Investigation process through on-line interactions with the Operations staff.

Provide a summary of the findings / investigation to the appropriate Business Unit representative.
22. Present data to customers / internal management with ease and without undue hardship.
23. Maintain positive external and internal customer relationships with face-to-face, email and voice
communication. Provide the appropriate feedback within 24 hours of notification.
24. Assist with Supplier Investigations as needed.
25. Assess and provide detailed reports / summaries on the impact of process changes to PCI management

Special Demands: The physical demands described here are representative