Quality Assurance Associate - Manufacturing Floor (Night Shift)

Role Summary

Quality Assurance Associate - Manufacturing Floor

Responsibilities

• 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 management documentation, deviations, investigations and CAPA records for completion. Write new documents and revise existing QA documents as needed.
• Participate and manage QA projects as needed with minimal supervision. Receive overall project direction from management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.

Qualifications

• BA/BS in any Life Science discipline, and 3 years’ experience in regulated industry (USDA, FDA, ISO etc).
• Must have direct experience with Quality Assurance within regulated industry (USDA, FDA, ISO, etc.)
• Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations.
• Must be able to work in controlled / clean room environments requiring gowning qualifications.

Skills

• Familiarity with basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Demonstrated experience making sound independent decisions.

Education

• Master's in any Life Science Discipline preferred.

Additional Requirements

• Must be able to work in controlled / clean room environments requiring gowning qualifications.
• Must be able to work nights and rotating weekends.