American Laboratories is seeking a qualified Compliance Analyst to add to our team!
American Laboratories was founded in 1967, based on the knowledge of manufacturing enzymes, proteins and flavors to various industries. 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. Through high quality products and customer service, American Laboratories has become an industry-recognized supplier for the products it manufactures.
American Laboratories offers competitive pay, an extensive benefits package and a fun, driven culture.
- Manage compliance improvement projects at ALI to assure cGMP (Current Good Manufacturing Practices) compliance.
- Works closely with the President and the Director of Compliance of the Company
- Participate and support with FDA (Food and Drug Administration), USDA (United States Department of Agriculture), EPA (Environmental Protection Agency) and other regulatory agencies during site inspections of the facilities.
- Ensuring adherence to QA (Quality Assurance) compliance SOPs (Standard Operating Procedures) and assure they are accurate, up-to-date and reflect current practice.
- Assisting with the training, development, maintenance, and monitoring of the key performance indicator and prepare reports as required.
- Write, review and approve operation documentation and quality and operation procedures
- Participate in internal cGMP audits as required.
- Assist with customer audits process including preparation and responses.
- Assist with planning company-wide Annual cGMP Training with ALI management.
- Assist with review and approval of Deviation/CAPA (Corrective Action and Preventative Action), change control and validation/qualification documents.
- Other duties as required.
WORK EXPERIENCE REQUIREMENTS
- 5 years of experience in an FDA-regulated environment.
- 5 years of experience with cGMP regulations.
- Excellent computer skills.
- Excellent communication skills
- B.A./B.S. Degree or appropriate combination of experience, education and training.