A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

This Senior Analyst, Quality Control role is accountable for supporting QCRM with Deviations, CAPAs, Change Controls, OOSs, Risk Assessments, and Supplier Change Notifications. This role will interface with Global Quality Control, Quality Operations, Supply Chain, MSAT, and other cross-functional teams as required.

The Senior Analyst, Quality Control reports to the Manager, Quality Control Raw Materials. The position is located at the RTP site and requires an onsite presence.

Position Responsibilities:

• Lead risk assessments and author technical reports for enrollment of new raw materials and components.

• 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.

• Present change controls to Change Control Review Board. Own change controls throughout the entire process

• Evaluate Supplier Change Notifications(SCN) and manage change controls related to SCNs to ensure closure in a timely manner.

• Provide subject matter expertise for raw materials and compendia testing.

• As needed, perform Impact Assessments and complete Change Actions for Change Controls.

• Own QCRM related deviations, CAPAs, and change controls.

• 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.

• Participate in cross-function teams to determine actions needed to support onboarding of new materials, projects, material release, last-minute requests, etc.

• Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits

Minimum Qualifications:

• Hands-on experience with the management of Change Controls, Deviations and CAPA is required.

• In-depth knowledge of Good Manufacturing Practices (cGMP).

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.

• Track record of driving a quality mindset with stakeholder groups and establishing expectations and processes within their team or department.

Preferred Qualifications:

• Bachelor’s degree or higher in Life Sciences discipline

• Minimum of 7 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 5 years in Quality Control, Quality Systems or Quality Assurance.

• Previous experience in Quality Control Raw Materials.

• Experience with Supply/Vendor Change Notifications.

• Experience performing risk assessments.

• Excellent oral and written communication skills with strong technical writing experience.

• Continuous Improvement Mindset.

• Knowledge of phase appropriate quality system and product lifecycle requirements.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

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 base pay hiring range for this position is $75,000.00 - $112,500.00 per year. 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.