Documentation Specialist

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). 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.

Take your career to the next level by applying today!

Documentation Specialist

We have a career opportunity for a Documentation Specialist. As a Documentation Specialist you will be responsible for organizing, controlling and maintaining the activities of American Laboratories, LLC's (ALI) Quality Assurance documentation and review procedures.

The specialist will be located in Omaha, working with different management levels and support personnel in other office locations.

The impact you will have:

o You will assist with the responsibilities for the control, issuing and archiving/scanning of documents, such as Manufacturing Instructions (MIs), Receiving Reports, Invoices and others as assigned. This will include scanning duties

o You will write and review documents and methods for use by the company and affiliates

o You will utilize good documentation practice (GDP) to ensure documents created or reviewed are complete, accurate, legible, contemporaneous, original and attributable (ALCOA)

o You will assist with the utilization of the MasterControl electronic document system

o You will assist Quality and Production personnel with the review of MIs, lab results, documents from suppliers, certificates of analysis and other documents for clarity and completeness

o You will close MIs, adding final product weight into inventory for further processing or final releasing

o You will track and trend documentation errors to detect and assess problems and communicate issues to Management

o You will assist the ALI audit team during regulatory and customer audits

What we are looking for:

o Bachelor's degree in a Science related field OR appropriate combination of education, experience and training

o 2+ years' experience in a pharmaceutical/food manufacturing environment includingn documentation creation, revision and control

o Experience with good documentation practices and manufacturing regulations (US FDA / FDA)

o Experience with Microsoft computer programs including Excel, Word, Outlook and Power Point

o Ability to manage multiple projects/tasks simultaneously

o Strong attention to detail, time management and organizational skills