Quality Compliance Professional - Production

Olon USA LLC

Painesville, OH

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JOB DETAILS

SKILLS

Application Programming Interface (API), Auditing, Change Requests/Orders, Cleaning Equipment, Corrective and Preventative Action (CAPA) Systems, Customer Support/Service, Documentation, Drug Manufacturing, Equipment Validation, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Maintain Compliance, Maintenance Services, Manufacturing, Manufacturing Requirements, Monitor Regulations, Process Validation, Production Control, Production Systems, Quality Assurance, Quality Management, Risk Analysis, Root Cause Analysis, Standard Operating Procedures (SOP), United States Department of Agriculture (USDA)

LOCATION

Painesville, OH

POSTED

3 days ago

Purpose: Ensure GMP compliance in API Production areas Responsibilities and Duties Review Batch Records directly during production phases Serve as liaison to production operators and shift leaders to provide support and guidance to ensure GMP compliance Communicate with Facility Maintenance team members to understand the control of the production environment during specific events that may impact the quality outcome of API Participate in the initiation or completion of deviations investigations and risk assessments for product quality events to include conducting root cause analysis and performing interviews with appropriate employees Collaborate in the drafting / revision of SOP and MBR, verify correct GMP application and alignment of performed operations with written instructions Review all GMP documentation related to the production area Evaluate change proposals and implementation Verify process documentation Ensure continuous auditing of production areas Oversee correct application of equipment cleaning procedures Review process validation, cleaning validation and equipment / facility qualification protocols Report critical quality situations to supervisors, evaluate solutions and implement directives Propose and monitor implementation and effectiveness of CAPAs related to area of responsibility Support client audits both during on site visits and during drafting of CAPA Plans Required Qualifications Must have direct experience with Quality Assurance within an regulated industry (USDA, FDA, ISO etc) Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations BA/BS degree in Science related field or manufacturing is highly preferred, however, strong experience in Quality Assurance in a regulated industry may be considered in absence of a 4 year degree 5 plus years experience as a Quality Professional required PI522cb1793188-25448-399474705c143e31-5e48-4549-b638-05792d185386

About the Company

Olon USA LLC

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