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Reference #: JR113109 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.

1. Perform operational production room approvals after product and lot changes
2. Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
3. 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.
4. 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
5. Review sampling pages to ensure samples have been taken, labelled, and documented appropriately
6. Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely.
7. Check to ensure portable equipment has been cleaned and documented correctly on quality form.
8. Review temperature and humidity data to ensure within acceptable job parameters.
9. 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
10. Support Root Cause Analysis as needed.
11. Performs/supports end of shift BR review and supports/completes FORM-0001908 (QA 903
12. Report quality event notifications for issues encountered on the production floor to OPS Mgmt.
13. Support operations by creating JDE labels for production and act as on floor SME for JDE transactions.
14. Confirm bulk material and components for job are correct and kept covered.
15. Ensure recovery stations are segregated from product flow.
16. This position may require overtime and/or weekend work.
17. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
18. Attendance to work is an essential function of this position
19. 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.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.