Job Details
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.
- 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
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.