POSITION SUMMARY:

Under the direction of the Director/Manager, Quality Systems, the Quality Systems Specialist is responsible for managing the elements of the Quality Systems including, but not limited to: Change Controls, Quality Events, Deviations, Corrective and Preventative actions, QMR, Risk Management. This individual works closely with cross-functional teams at the site and abroad. This individual will routinely report on quality system and business process performance; proactively identifying, providing guidance and implementing process and system improvements to resolve complex issues in a timely manner.

Education :

Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent

Experience :

Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills :

• understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.
• be proactive, results-oriented with a strong attention to detail and strong time management skills.
• to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment.