Quality Ops Manager

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

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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.

Job Title

Quality Operations Manager

Department/Group:

QC Inspection

Location

Philadelphia

Reports to

Senior Quality Operations Manager

FLSA Status

Exempt

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.

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

and continuous process improvement.

1. Oversee process improvements for Label room functions

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

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

4. Act as "back up" for any Quality Operations Supervisor during time of vacation or absence

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

6. Facilitate investigations for internal process events or deviations

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

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

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

10. Performs other duties as assigned by Senior Manager/Director.

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

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

From 1/4 to 1/2 of the day.

Move, Traverse:

From 1/4 to 1/2 of the day.

Communicate or exchange information

From 1/2 to 3/4 of the day.

Detect, distinguish, or determine:

Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

This position may have the following special vision requirements.

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Close Vision

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Distance Vision

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Color Vision

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Peripheral Vision

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Depth Perception

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Ability to focus

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No Special Vision Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for

various lengths of time.

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Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.

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Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/4 to 1/2 of the day.

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Work near moving mechanical parts for up to 1/4 of the day.

The noise level in the work environment is typically, loud.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.

• Basic Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

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High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may

be provided in various forms.

• Other Required Skills.

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.

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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (~~~/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled