Quality Operations Manager

4 weeks ago

Philadelphia, United States PCI Pharma Services Full time

Summary of Objective:

This position is responsible for overseeing the direction, training, organization, alignment, monitoring, and cGMP

compliance to ensure we deliver a safe and quality product. This position will oversee both the Quality

Auditor and Label Room teams. This is a supervisory position of approximately 7-10 direct reports across various shifts.

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. Coach, mentor, train the Quality Operations Supervisors and Label Room Personnel to develop them from a Quality and cGMP perspective.

2. Assess risks in accordance with the guidance delineated in ICH Q9, ISO, 21CFR, and EU guidelines and develop robust and sustainable solutions

3. Investigates, analyzes, and reports key quality metrics as it relates to the Quality Auditors and Label room

team members.

4. Partner with Operations to train, mentor and coach the production personnel to foster an environment of proactive

and continuous process improvement.

5. Oversee process improvements for Label room functions

6. Ensure proper team head count is maintained based on workload

7. Observe and correct and Quality deficiencies on the production floor or in individual packaging suite

8. Act as “back up” for any Quality Operations Supervisor during time of vacation or absence

9. Ensure processes for creation of shipper labels are compliant with Regulatory, customer, and PCI requirements

10. Facilitate investigations for internal process events or deviations

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 Senior Manager/Director.

15. Perform Root Cause Analysis on event and deviations related to room approval failures and line clearance failures


Preferred:

- Ability to identify and resolve problems in a timely manner.

- Ability to work independently and/or part of a team.

- Ability to show success in managing employees.

- Ability to display excellent time management skills.

-5 to 7 years of experience

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