QUALITY ASSURANCE MANAGER jobs in Fremont, NE

ALI Pharmaceutical Manufacturing (ALI-PM) is a great employee focused company to work for!

At ALI-PM, we are looking for candidates with varied backgrounds and skills. Diverse ideas come from diverse people, and we are devoted to offering an all-encompassing work environment where everyone feels valued and respected. Our pace of work enables fast learning and fosters an environment where you can stretch yourself and make an impact. We offer a variety of job specific and business skills programs and trainings to our employees. As a member of our team, you’ll have an opportunity to draw from those resources when you need them, and likewise, contribute your expertise when you have something to share.

We offer a highly competitive compensation package (salary and bonus) as well as a comprehensive, family-friendly benefits package including:

• Exceptional family medical, dental, and vision benefits (100% company paid premiums). 100% paid deductible/out of pocket expenses for Medical
• Paid time off and sick leave
• 9 paid holidays
• Exceptional 401k fund contributions (up to 9%)
• Great schedules
• Wellness incentives

Take your career to the next level by applying today!

Pay is based on experience.

Manager of Quality Assurance

We have a career opportunity for a Manager of Quality Assurance. As a Manager of Quality Assurance, you will be responsible for oversight and management of Operational Quality Assurance resources as part of ALI Pharmaceutical Manufacturing’s (ALI-PM) organization.

This position will be located at 4410 S 102nd St., Omaha, NE, working with different management levels and support personnel in other office locations.

The impact you will have:

• You will manage ALI-PM’s Operational Quality Assurance to be compliant with Quality Policies and Standards.
• You will lead the Operational Quality Assurance team.
• You will write, review and/or approve Deviations, Change Controls and Manufacturing Instructions.
• You will be responsible for releasing in process and finished products.
• You will conduct/assist in investigations of deviations and CAPAs; Out of Specifications (OOS’s) for Release/Stability and Out of Trends (OOT’s).
• You will support the ALI-PM QC testing and sample management program.
• You will 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.

Job Type: Full-time

Pay: $85,000.00 - $105,000.00 per year

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: 3 years (Required)
• supervisory: 5 years (Preferred)
• Quality assurance: 4 years (Required)

Work Location: In person