Production supervisor

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 :

Due to business needs and necessity all schedules are subject to change 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-0001908 (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 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.

The noise level in the work environment is typically, choose an item.

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 :

• High School Diploma or GED and / or 1-3 months related experience and / or training.
• Basic Mathematical Skills
• Basic Computer Skills : Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Full Professional Proficiency : Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning : Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract / concrete variables.
• Other Required Skills.

Preferred :

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to show success in managing employees.

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-0001908 (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 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.

The noise level in the work environment is typically, choose an item.

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.

Preferred :

• Ability to work independently and / or as part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to show success in managing employees.

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.

Last updated : 2024-06-14