Quality Assurance Associate – Manufacturing Floor (Evening & Night Shift)

Job Description

Your Role: 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.

What You Need to Succeed (Minimum Qualifications)

• Bachelor’s Degree (or Master's) in any Life Science discipline preferred, and/or 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.

What Will Give You the Competitive Edge (Preferred Qualifications)

• 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.

Additional Information

• Location: Elwood, KS Manufacturing Site
• Shifts: Evening Shift: 4:00pm - 12:30am & Night Shift: 12am - 8:30am, Monday - Friday Rotating weekend schedule required (every 3rd weekend)