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Manager of Quality Systems

American Laboratories
Omaha, NE
Closing date
Sep 22, 2023

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American Laboratories is a great employee focused company to work for!

American Laboratories is a growing multi-industry supplier for the extensive products it manufactures. We were founded in 1967 based on the knowledge of manufacturing enzymes, proteins, and flavors to various industries. Today, American Laboratories' food and pharmaceutical divisions employ over 125 people, offering an extensive listing of over 300 products to the Human Pharmaceutical, Human Nutritional, Food Processing, and Animal Health industries in the United States and 45 countries around the world.

At American Laboratories, 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), paid time off, 401k with company match, employee short-term and long-term disability, and basic life insurance (100% company paid premiums), great schedules, wellness incentives, and all-around great people to work with. Take your career to the next level by applying today!

Manager of Quality Systems

We have a career opportunity for a Manager of Quality Systems. As a Manager of Quality Systems, you will be responsible for oversight and management of American Laboratories' (ALI) Quality Systems and department.

This position will be located in Omaha, NE, working with different management levels and support personnel in other office locations.

The impact you will have:

  • You will manage ALI's Quality Systems Program that includes: Deviations/Corrective and Preventative Actions (CAPA), Change Control, Supplier Qualification, KPI and Environmental Program.

  • You will write, review and/or approve Deviations, Complaints, Quality System Standard Operating Procedures, Change Controls and Specifications.

  • You will write, review and/or approve manufacturing instructions and/or batch records.

  • You will be responsible for product release activities including batch record review, product disposition, returns, salvages, recalls, product improvement and product annual review.

  • 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 be responsible for the oversight of the training program documentation at ALI-PM. Provide training as required.

  • You will write, review and/or approve OOS, including stability OOS.

What we are looking for:

  • You will have a Bachelor's degree in a scientific discipline.

  • You will have a minimum of five (5) years of experience with FDA and cGMP requirements in a pharmaceutical environment.

  • You will have a minimum of five (5) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.

  • You will have an advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.

  • You will have excellent time management and organization skills.

  • You will have strong written and verbal communication and employee relation skills.

  • You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.

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