Quality Unit Investigation Specialist

American Laboratories is a great company to work for!

American Laboratories is a growing (yet, still small, think family-like feel), 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. We are celebrating our 55th anniversary this year! Today, American Laboratories employs over 100 people, offers an extensive listing of over 300 products to the Food Processing, Animal Health and Nutritional 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). 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

Pay is based on experience.

Quality Unit Investigation Specialist

We have a career opportunity for a Quality Unit Investigation Specialist (QUIS). As a QUIS, you will be responsible for American Laboratories, LLC’s (ALI) quality investigations.

The QUIS will be located at one of American Laboratories' south locations, working with different management levels and support personnel in other office locations.

The impact you will have:

• You will support quality investigation activities regarding quality events such as deviations, out of specification and out of trend laboratory investigations, and corrective and preventive actions (CAPAs).
• You will support for quality events will include identification of root causes and corrective and preventative actions.
• You will write and review deviations, out of specification, complaints, quality system standard operating procedures, change control and CAPAs.
• You will support documentation process activities in collaboration with other departments and other project teams.
• You will participate in and report Quality department performance outputs during management reviews and Current Good Manufacturing Practices (cGMP) meetings.
• You will prepare and analyze quality system key performance indicators through the use of bracketing and trending.
• You will provide coaching and training to staff at regular intervals to better document investigations.
• You will conduct and/or assist with audits supporting the ALI internal and external audit programs.
• You will proactively propose and implement continuous improvements of quality systems and procedures.

What we are looking for:

• High School Diploma, GED or equivalent required.
• Bachelor's degree in science preferred.
• Minimum of 3 years of experience with US FDA and cGMP requirements.
• Minimum of 3 years of experience with QA and/or QC practices.
• Ability to translate skill and knowledge to others and to interpret regulations.
• Basic understanding of manufacturing in cGMP environment, documentation, and data integrity requirements.
• Highly strategic as well as hands on, detail-oriented and metric driven.
• Ability to manage multiple projects/tasks simultaneously.
• Strong attention to detail, time management, and organizational skills.
• Advanced computer skills, including Outlook, Excel, Word, PowerPoint.
• Good written and verbal communication skills.

American Laboratories is an Equal Opportunity Employer and participates in E-Verify.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime
• Weekends as needed

Experience:

• US FDA and cGMP requirements: 3 years (Required)
• QA/QC practices: 3 years (Preferred)
• CAPAs: 3 years (Required)

Ability to Relocate:

• Omaha, NE 68107: Relocate before starting work (Required)

Work Location: In person