Sterility Assurance Specialist Senior QA Consultants

Sterility Assurance Specialist senior QA Consultants, Kankakee, IL on site near Chicago with a possibility of extensionResponsibilities
• Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
• Leads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates
• Performs trending to identify and report adverse trends that may require further action
• Completes investigations within the specified time-frames
• Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective
• Reports performance metrics to Project Leader on a periodic basis

Requirements
• Bachelor’s degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• At least 7 years of experience in Pharmaceutical industries, with biologics and/or biotech products preferred
• Knowledge and experience with aseptic processing
• Expert level understanding of deviation resolution for manufacturing processes and CAPA management
• Previous experience with remediation plans for the FDA
• Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)

Sterility Assurance Specialist senior QA Consultants, Kankakee, IL on site near Chicago with a possibility of extensionResponsibilities
• Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
• Leads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates
• Performs trending to identify and report adverse trends that may require further action
• Completes investigations within the specified time-frames
• Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective
• Reports performance metrics to Project Leader on a periodic basis

Requirements
• Bachelor’s degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• At least 7 years of experience in Pharmaceutical industries, with biologics and/or biotech products preferred
• Knowledge and experience with aseptic processing
• Expert level understanding of deviation resolution for manufacturing processes and CAPA management
• Previous experience with remediation plans for the FDA
• Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)