Associate Ii, Quality Control - Raw Materials

• Perform viral assessment and author technical reports for new materials added to manufacturing processes.
• Assist in Raw Materials disposition.
• Own deviations, CAPAs and Change Controls.
• Perform gap assessments between global and local procedures.
• Complete actions to implement and close CAPAs.
• Evaluate Vendor Change Notifications (VCNs) • Present change controls in Change Control Review Board and manage Change Controls, related to Vendor Change Notifications, to ensure closure in a timely manner.
• Perform risk assessment and author technical reports for enrollment of raw materials and components for new manufacturing processes and open-container raw material expiry.
• As needed, perform Impact Assessments and complete Change Actions for Change Controls.
• Perform, review and approve specifications revisions.
• Provide support for audits. Assists in actions needed to address observations. Write audit responses.
• Provide subject matter expertise for raw materials and compendia testing.
• Work with QCRM Manager to create and delegate actions to ensure that Manufacturing has materials released on-time.
• Train junior analysts in QMS records tasks: change control process, Good Documentation Practices, Good Manufacturing Practices, SOP revisions, Specification revisions.
• Participate in cross-functional teams to determine actions needed to support onboarding of new materials, projects, materials release, last-minute requests, etc.

• 5 years of related experience (QA/QC)
• Bachelor's Degree

• Experience with Raw Materials
• Experience with Technical Writing
• Experience with Change Control, Deviations

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $72,000.00 - $91,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.