Associate Quality Account Mgr II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

Responsible for leading efforts in planning, directing, and coordinating customer focus team Quality activities in order to ensure that the quality of PCI’s products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.  

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. Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning.

2. Responsible for direct supervision and personnel development including training and mentoring of direct reports.

3. Customer contact for quality activities and management of customer expectations.

4. Attend conference calls and customer meetings; provide complaint and quality related information.

5. Prepares annual product review data as required for customers and routes for internal approval.

6. Generate and present quality related metrics and key performance indicators for team’s performance to internal BU members and PCI Management.

7. Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications.

8. Assist with organizing internal and customer approval of batch records and specs.

9. Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.

10. Lead Quality improvement projects both within Quality departments and in cross-functional team environments

11. Assist as company liaison with customers concerning quality control documentation.

12. Help identify, communicate, track and resolve document related issues with other departments and customers.

13. Assist with addressing quality events with Production and QC teams.

14. Timely provision of reports and requested information to customers.

15. Function as the customer point for any comments or questions pertaining to defect events and

investigations.

16. Investigate and document investigation in formal report.

17. Enter, monitor, track, extend and close investigations and CAPA information in Pilgrim.

18. Meet with management to address issues or concerns with the deviations.

19. Review and approve internal and customer-based specifications for packaging components and processes.

20. Manage customer visits.

21. May include travel to meet with customers on projects and attend Business reviews.

22. This position may require overtime and/or weekend work.

23. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

24. Attendance to work is an essential function of this position.

25. Performs finish product batch release of approved production lots.

26. Performs other duties as assigned by Manager/Supervisor.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

- Stationary Position: 3/4 of the day and up.

- Move, Traverse: From 1/4 to 1/2 of the day.

- Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.

- Install, place, adjust, apply, measure, use, or signal: None.

- Ascend/Descend or Work Atop: None.

- Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.

- Communicate or exchange information: 3/4 of the day and up.

- Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can exp