PCI Pharma Services
| Company Name: | PCI Pharma Services |
| Company Website: | www.pci.com |
| Job Type: | Full-time |
| Job Location: | Philadelphia, PA |
| Job Posted Date: | 20-04-2023 |
| Posted on: | jobscastle.net |
Job’s Overview:
PCI Pharma Services is seeking a Quality Ops Manager in Philadelphia, PA. Please take a moment to read the job post below if you are interested:
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.
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.
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.
- Coach, mentor, train the Quality Operations Supervisors and Label Room Personnel to develop them from a Quality and cGMP perspective.
- Assess risks in accordance with the guidance delineated in ICH Q9, ISO, 21CFR, and EU guidelines and develop robust and sustainable solutions.
- Investigates, analyzes, and reports key quality metrics as it relates to the Quality Auditors and Label room team members.
- Partner with Operations to train, mentor and coach the production personnel to foster an environment of proactive
and continuous process improvement.
- Oversee process improvements for Label room functions.
- Ensure proper team head count is maintained based on workload.
- Observe and correct and Quality deficiencies on the production floor or in individual packaging suite.
- Act as “back up” for any Quality Operations Supervisor during time of vacation or absence.
- Ensure processes for creation of shipper labels are compliant with Regulatory, customer, and PCI requirements.
- Facilitate investigations for internal process events or deviations.
- This position may require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attendance to work is an essential function of this position.
- Performs other duties as assigned by Senior Manager/Director.
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.
Operate, Activate, Use, Prepare, Inspect, Or Place
None
Install, Place, Adjust, Apply, Measure, Use, Or Signal
None.
Ascend/Descend Or Work Atop
None.
Position Self (to) Or Move (about Or To)
None.
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.
☒
Close Vision
☐
Distance Vision
☐
Color Vision
☐
Peripheral Vision
☐
Depth Perception
☒
Ability to focus
☐
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.
Work is primarily performed at a desk and/or in an office environment.
for 1/4 to 1/2 of the day.
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.
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.
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.
- If other, please type here.
- If other, please type here.
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.
Getting the Quality Ops Manager designation comes with some responsibilities. It would be a wise idea to take a few minutes to learn more about it so you can make an informed decision.
Applicants must meet the above-mentioned requirements in order to qualify for consideration to work as a Quality Ops Manager.
By clicking on the apply now button, you will be redirected to the official recruitment website where you can fill out your application.
