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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.
*Due to business needs and necessity all schedules are subject to change*
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 (https://pci.com/)
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