Senior Analyst, Quality Control

• Evaluate Supplier Change Notifications(SCN) and manage change controls related to SCNs to ensure closure in a timely manner.
• Lead risk assessments and author technical reports for open-container raw material expiry.
• Support phase appropriate new material enrollment. Participate, and as required lead, material enrollment board and drafting of raw material specifications.
• As needed, perform Impact Assessments and complete Change Actions for Change Controls.
• Lead risk assessments and author technical reports for enrollment of new raw materials and components.
• Participate in cross-function teams to determine actions needed to support onboarding of new materials, projects, material release, last-minute requests, etc.
• Present change controls to Change Control Review Board. Own change controls throughout the entire process
• Own QCRM related deviations, CAPAs, and change controls.
• Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits
• Provide subject matter expertise for raw materials and compendia testing.
• As needed, perform routing testing on raw materials such as pH, conductivity, appearance, and full compendia (USP) gas testing.
• As needed, assist with inspection and sampling activities of raw materials and components.

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.
• Minimum of 7 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 5 years in Quality Control, Quality Systems or Quality Assurance.
• Hands-on experience with the management of Change Controls, Deviations and CAPA is required.
• In-depth knowledge of Good Manufacturing Practices (cGMP).
• Track record of driving a quality mindset with stakeholder groups and establishing expectations and processes within their team or department.
• Bachelor’s degree or higher in Life Sciences discipline

• Knowledge of phase appropriate quality system and product lifecycle requirements.
• Experience with Supply/Vendor Change Notifications.
• Experience performing risk assessments.
• Continuous Improvement Mindset.
• Previous experience in Quality Control Raw Materials.
• Excellent oral and written communication skills with strong technical writing experience.

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 $85,000.00 - $111,250.00. 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.