Director, Compliance #LI-PG1

American Laboratories is a great 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 employs over 125 people, offers 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, 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!

Director of Compliance  

We have a career opportunity for a Director of Compliance that is responsible for ALI’s compliance with the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), Environmental Protections (EPA) and all other state, city and local regulations.

The position will be located at 11128 John Galt Blvd, Ste 500, Omaha, NE 68137, working with different management levels (including the Board of Directors, CEO, President, CFO, Vice Presidents) and support personnel in all other locations.

The impact you will have:

• You will lead and oversee  ALI’s Compliance, Regulatory Affairs and Safety systems.
• You will ensure we are within FDA compliance, including inspection preparation, training and readiness in all facilities.
• You will Audit and work closely with internal and external partners to assure current Good Manufacturing Practices (cGMP) compliance.
• You will assist with the training, development, maintenance and monitoring of the various departmental tracking systems and to prepare reports as required.
• You will review and approve validation protocols, facility and equipment change control documents and equipment qualification reports as applicable.
• You will assist QA in various capacities, including oversight and monitoring of the internal and external audit schedules and programs, documentation practices and systems.
• You will lead and coordinate company-wide cGMP training.
• You will write, review and approve Compliance, Regulatory and Safety  documentation.
• You will direct/coordinate outside consultants for cGMP and regulatory requirements.

What we are looking for:

• You will have a bachelor’s degree in a science related field and have a minimum of seven (7) years (combined) work experience with the following:
  • FDA Q7 and current Good Manufacturing Practices (cGMP)
  • FDA regulations and practices (21 CFR 11, 21 CFR 111, 21 CFR 117 and/or 21 CFR 210/211)
  • Compliance, Regulatory Affairs, Quality Assurance practices
• You will have a strong understanding of compliance, regulatory ,quality assurance practices, manufacturing processes, cGMP, documentation, and data integrity requirements.
• You will have experience with supervising others.
• You will have strong written and verbal communication skills.
• You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.