Manager of Quality Assurance jml

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Rare Opportunity to relocate to Omaha, NE. They are willing to provide a relocation bonus upon acceptance of an applicant. Willing to negotiate on a case-by-case senario.

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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.

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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)

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