The Compliance Manager will be responsible for managing all compliance aspects of the production site and ensure all products are manufactured in compliance with 21CFR111 requirements. Additionally, this individual will be the Virginia representative responsible for compliance and EHS.
- Participate in the overall review of the Quality Assurance Program
- Create and manage quality documents, including Standard Operating Procedures, Batch Production Records, HACCP Plan, and associated records
- Coordinate Quality, Compliance, and Safety training and coaching site-wide and provide guidance with compliance and regulatory topics
- Work cross-departmentally with Supply Chain to ensure the quality of incoming raw materials
- Collaborate with Production to achieve overall company objectives while ensuring quality standards are maintained
- Implement and enforce cGMP principles, including in the manufacturing areas
- Lead and initiate the troubleshooting of existing systems, equipment, and processes to improve overall product quality and food safety
- Support audit preparation, conduct audit and compliance activities and obtain and maintain the facility and regulatory certifications.
- Support technical and production staff
- Provide quality guidance to employees
- Responsible for executing the internal audit program
- Develop processes and procedures to implement the quality management system
- Develop processes and procedures to ensure compliance with Environmental Health and Safety regulations
- Responsible for effectively communicating and escalating product quality problems to management
- Responsible for ensuring a state of cGMP readiness for the site that ensures successful regulatory inspections
- Performs other responsibilities as assigned
EDUCATION & EXPERIENCE
- Bachelor of Science degree of Science in any field required, Master of Science degree preferred
- Minimum of 5 years Quality Assurance experience
- Experience working with EH&S policies and procedures
- Experience working in a regulated environment or on a team with ISO 9001 certification
- Experience with cGMP, 21CFR111, and 21CFR 110/117 required.
- Experience and/or training in internal auditing
- Experience with production, manufacturing process flows, and lean manufacturing.
- Must be a highly motivated self-starter capable of working independently and provide updates to stakeholders as requested
- Microsoft Office skills
- Must pass a drug test and criminal background check
- Constantly perform desk-based computer tasks
- Frequently sitting and standing
- Occasionally Twist/bend/stoop/squat, kneel/crawl
- An environment with minimal noise levels
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
Dalitso is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
We offer benefit packages that may include: Medical, Dental, Vision, Life, Short, and Long Term Disability, Flexible Spending Accounts, Paid Time Off, and Paid Holidays.