Quality Compliance Professional - Production

Olon USA LLC • Concord Township, OH

29d

About The Position

Purpose: Ensure GMP compliance in API Production areas

Requirements

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level