layiq
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Bedford, NH, USA; USA_NH_Bedford
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.
This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations. The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.
Responsible for compliance relative to the overall Supplier Qualification Program by scheduling and conducting supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports.
Responsible for follow up and tracking of supplier audit observations to ensure timely closure.
Monitor, communicate, and reconcile supplier change notifications, supplier non-conformances, and complaints.
Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
Drafting, review, and management of supplier quality assurance agreements and non-disclosure agreements.
Collaborate with Corporate Supplier Quality team members; align on Supplier Qualification program initiatives, report status of site-specific Supplier Qualification actions.
Support Supplier Risk Assessments.
Support Annual Product Quality Review’s.
Support Quality System Events impacting the Supplier Quality program.
Request, reconcile, and file Supplier Qualification documentation from vendors.
Track and maintain KPI metrics for the Supplier Qualification program.
Writes and revises Standard Operating Procedures (SOP).
Support continuous improvement initiatives.
Ability to travel 10-20%
Performs other duties as assigned.
Is assigned tasks and duties regularly from direct manager and senior team members.
Ability to work independently with moderate support from direct manager.
Ability to maintain organization of assigned tasks and meet deadlines.
Ability to think strategically and tactically.
Frequent reading, writing, and verbal communication.
Able to work in a highly complex and regulated environment.
Able to translate ideas to actual concepts and processes.
Interacts with all departmental staff, external clients and suppliers.
TRAVEL – 10-20%
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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