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 product lot disposition by reviewing executed manufacturing batch records for completeness, accuracy, and compliance to GMP and company procedures.
• Perform document change control activities as needed.
• Perform and lead in investigations, NCMRs and Complaints.
• Track and monitor CAPAs.
• Perform training as needed.
• Support Distribution and Labeling activities.
• Collect Quality Metrics.
• Support the Sterile Fill and Finish Quality Manager with internal, supplier, regulatory and customer audits.
• Perform line clearances, in-process checks and monitoring of sterile manufacturing and finished product visual inspection.
• Perform finished product visual inspection or incoming release of incoming GMP materials according to appropriate material specifications
• Ensure department and company goals are met.
• Reviews completed documentation and provides recommendation for process improvements to support existing procedures for continual improvement in conjunction with management.
• Capable of supporting sampling, packaging, and labeling operations.
• Performs GMP tasks by executing steps as written through established procedures with minimal supervision.
• Effectively communicates both verbally and in writing with all levels
• Performs setup and operation of equipment such as Isolators, Visual inspection light booth, and Biological Safety Cabinets.
• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

The base salary range for this position is $67,840 to $93,280 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise

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Join us and be part of building the bridge between life changing therapies and patients.

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.