Phl production Supervisor - Philadelphia, United States - PCI Pharma Services

PCI Pharma Services

Verified Company

Philadelphia, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

Job Title:
Production Supervisor

Department/Group:
Operations

Location:
Philadelphia

Reports to:
Operations Manager - 3rd shift

FLSA Status:
Exempt

Summary of Objective:

This position directly supports the direction, organization, alignment, monitoring and cGMP compliance to ensure the successful, cost effective, timely and safe packaging of customer orders.

The position audits production room documentation, checks equipment challenges, in-process inspections and ensures samples/AQL requirements are met.

These associates are responsible for performing real time batch record and documentation review and or co-signs during batch processing to drive improvements into our Right First Time (RFT) metrics.

They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts.

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.

Perform operational production room approvals after product and lot changes
Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
Ensure products are packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this will contact the appropriate personnel to recalibrate and/or remediate the issue.
Review batch record (MPI's) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet AQL requirements
Review sampling pages to ensure samples have been taken, labelled, and documented appropriately
Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely.
Check to ensure portable equipment has been cleaned and documented correctly on quality form.
Review temperature and humidity data to ensure within acceptable job parameters.
Identify proactively gaps in batch records and TER's to mitigate deviations and documentation errors. Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed
Support Root Cause Analysis as needed.
Performs/supports end of shift BR review and supports/completes FORM QA 903
Report quality event notifications for issues encountered on the production floor to OPS Mgmt.
Support operations by creating JDE labels for production and act as on floor SME for JDE transactions.
Confirm bulk material and components for job are correct and kept covered.
Ensure recovery stations are segregated from product flow.
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 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: From 1/4 to 1/2 of the day.
Move, Traverse: From 1/2 to 3/4 of the day.
Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
Install, place, adjust, apply, measure, use, or signal: From 1/4 to 1/2 of the day.
Ascend/Descend or

Work Atop:
Up to 1/4 of the day.

Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
Communicate or exchange information: 3/4 of the day and up.
Detect, distinguish, or determine: 3/4 of the day and up.

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