Manager of Quality Assurance gea
The impact you will have:
• Manage Operational Quality Assurance to be compliant with Quality Policies and Standards.
• Lead the Operational Quality Assurance team.
• Write, review and/or approve Deviations, Change Controls and Manufacturing Instructions.
• Responsible for releasing in process and finished products.
• Conduct/assist in investigations of deviations and CAPAs; Out of Specifications (OOS’s) for Release/Stability and Out of Trends (OOT’s).
• Support the testing and sample management program.
• Identify and execute quality related processes and projects.
What we are looking for:
• A Bachelor’s degree in a scientific discipline, preferred.
• Minimum of five (5) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
• Minimum of five (5) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
• An advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
• Excellent time management and organization skills.
• Strong written and verbal communication and employee relation skills.
• Proficiency in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.
Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance
Schedule:
• 8 hour shift
• Day shift
• Monday to Friday
Education:
• Bachelor's (Required)
Experience:
• FDA regulations: 5 years (Required)
• Quality assurance: 5 years (Required)
• Supervisory: 5 years (Required)