As Quality Assurance Manager II, you will not only you work for an amazing growing company, you will have the ability to make a footprint with your quality and leadership expertise! We are looking for a collaborator who enjoys a variety of day to day, project and transformational activities!
In this role, you will be involved with developing, interpreting, and implementing quality procedures, managing the quality systems, and facilitating regulatory compliance, customer and third-party audits. The position will manage QA operations to support cGMP manufacturing, testing and releases of finished product under FDA regulations, applicable international regulations, GLP standards and internal procedures. In addition, the position will conduct investigations into product safety or cGMP-related issues, management of change control, product complaint process, SOP preparation/revisions, CAPA system and cGMP training programs.
We are looking for the following skills and experiences:
Bachelor of Science degree or higher in scientific field. Strong background in microbiology preferred.
Seven years progressive complex experience in Quality Assurance, including 3 years experience supervising and managing staff in an industrial or manufacturing setting.
Prior work experience desired in a leadership role in a GMP manufacturing environment (cosmetic, OTC drug or device).
Strong verbal, written, analytical and interpersonal skills. Ability to organize and prioritize workload to meet deadlines.
American Society of Quality (ASQ) technical certification (Quality Auditor, Six Sigma, Quality Engineer, Quality Manager) preferred.
Must be proficient in Microsoft Office. Understanding or Statistical Process Control desired.
Ability to travel to other sites up to 20%.