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PCI
Philadelphia, PA, USA; USA_PA_Red Lion Road
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
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.
Assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
Prepares and distributes required documentation for requested production work orders.
·Perform documentation review of completed orders to ensure compliance with cGMP’s and customer requirements.
·Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications.
·Prepares customer required samples for shipment according to approved shipping instructions.
·Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
·Organize internal and customer approval of batch records and specs.
·Perform record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements.
·Help identify, communicate, track and resolve document related issues with other departments and customers.
·Function as one of the customer points for comments or questions pertaining to batch records.
·Initiating supplier non-conformance reports and effectuates material control.
·Prepares planned deviation requests when needed.
·Adherence to PCI and cGMP policies, procedures, rules and regulations.
·Attendance to work is an essential function of this job.
·May perform duties of Quality Auditor as assigned by Supervisor/Manager.
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