QA Documentation Specialist III

Description

100% on-site

The QA Engineer is responsible for ensuring the timely development, review and approval of all engineering, validation and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with corporate procedures, SOPs, cGMP, standards and implementing industry best practices.

• Responsible for the Quality review and approval of engineering and validation documentation to support requirements Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ); validation master plans, risk assessments, calibration and periodic reviews, etc.
• Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices ("cGMP") & supports validation.
• Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
• Represent QA in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation).
• Create, review, and approve SOPs, Change Control and Corrective Action Preventive Action (CAPA) and additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
• Works directly with operating entities, with multiple functions, internal and external, to provide Quality validation support to assure requirements meet project expectation and meet local procedures and regulations.
• Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve process issues and implement changes.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.
• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Participate in internal, client and/or regulatory audits.
• Work with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Establish, maintain, trend and report Quality KPI and metrics.
• Participate in Management Review, Quality Review Board Deviation Review Board and Change Review Board as required.
• Other tasks as assigned by Senior Manager of QA Operations.