Paragould , AK , United States
Manage all functional aspects of the Quality Assurance (QA) department to ensure product quality and site compliance to FDA requirements and supervise QA personnel and systems.
Ensures adherence to and compliance with established company quality policies practices SOPs and federal regulations. Manage the quality assurance department all associated office activities auditing staff QA Engineers and Supervisors for solid-dose and liquid manufacturing and packaging operations.
Monitor and promote Quality Awareness and Regulatory Compliance for the entire site. Participate in investigations of process deviations and assist in determining disposition for non-conforming bulk and finished product as well as packaged materials. Direct support for the staff will be necessary in terms of monitoring planning and scheduling and tracking all the necessary office responsibilities to meet the business requirements.
Requirements: Minimum of 2 to 5 years experience in the pharmaceutical or similarly regulated industry preferably in a Quality Assurance or Validation related position. Knowledge of regulatory environment. Excellent oral and written communication skills. Excellent organizational skills. Proven decision-making ability. Proven personnel development ability. Good presentation skills.
• EDUCATION: BS or BA preferably with related technical background.