Actively interact with Manufacturing and champion compliance through leadership and example in daily processes. Provide quality floor support, including observing daily active processes for: statuses, issues, concerns, and issuance of cell banks. Act as first responder for manufacturing activities and represent QA on cross-functional process teams.

Identify, investigate, and resolve complex technical issues using problem-solving skills. Participate in investigation teams, determine next steps and assist in the proper close out and follow up actions. Make decisions independently and notify management of actions taken.

Perform QA review/approval of controlled documents including, but not limited to, solution records, batch records, logbooks, autoclave cycles with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.

Review change mana...