Job Descriptions: GENERAL SUMMARY: Evaluate non-conformances and assess quality impact, recommend corrective actions and follow up to ensure corrective actions implemented are effective. Provide QA presence in the Facility and Metrology areas by conducting compliance walkthroughs and ensure compliance with FDA and other regulatory agency requirements. Partner with Facility and Metrology personnel to resolve compliance issues and ensure a successful compliance profile. Ensure compliance observations associated with ImClone Facilities are adequately addressed and completed on schedule. Review standard operating procedures, validation protocols/reports, Work Orders and Job Plans. Interact with FDA and other regulatory agencies, as required. Requires ~10% travel. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1.Provide QA presence in Facilities and Metrology areas through periodic walk throughs, participation in meetings and through systems review. 2.Identify opportunites for continuous improvement. 3.Evaluate Facility and Metrology non-conformances and assess quality impact. Recommend corrective actions as required. 4.Actively participate in cross functional team discussions of non-conforming events. 5.Review and approve Facility and Metrology SOP’s, trending reports, validation qualification reports, Work Orders and Job Plans. 6.Serve as the technical expert for Facilities, Utility Room and Metrology Labs compliance. 7.Participate in Compliance/Change Management Team Meetings. 8.Review Facility and Metrology change controls linked to non-conformance events. 9.Provide technical support to Manufacturing Compliance in areas relating to manufacturing/facilities investigations. 10.Participate in the harmonization of Facilities and Metrology document/systems. 11.Participate in Regulatory Inspections as scribe/runner. 12.Provide necessary backup to Facilities Compliance Associate Director. Required Experience: ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE: 1.A BA/BS degree in the sciences or equivalent experience. 2.Minimum of 4 years experience in the Biopharmaceutical industry including 1-3 years experience in Quality Assurance. 3.Thorough understanding of cGMP regulations for Facilities/Utilities and Metrology applications is required. Prior investigation/CAPA experience required. 4.Is famililar with Biotech manufacturing procedures and processes. 5.Excellent written and oral communication skills and must be computer literate. Keyword: Metrology, Facilities, HVAC, Utility Room From: Pharmaceutical Associates,LLC
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