Associate II, Quality Assurance

General Company Description

Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

Position Summary & Role

The Quality Specialist will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will understand cGMP, explicitly building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing.

Job Responsibilities

• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
• Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.
• Maintain a presence of Quality Assurance on the manufacturing floor during GMP runs to ensure compliance to GMPs.
• Escalate any events occurring on the manufacturing floor to Management.
• Review deviations, change controls, and/or CAPAs, as needed.
• Review batches manufactured at the East Norriton facility, as needed.
• Author and review technical documents, including but not limited to SOPs, and various quality reports.
• Perform Facility changeovers and Line clearances.
• Issuance of product labels, as needed.
• Release of GMP materials utilized in the manufacturing process as needed.

Preferred Experience, Education & Qualifications

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• Familiarity with electronic quality systems/software applications.
• Familiarity with laboratory and manufacturing execution systems.
• Working knowledge of GLP/GCP and GxP Regulatory requirements.
• Experience in preparation and participation in regulatory authority plant/site inspections.
• Experience supporting biologics manufacturing.
• Excellent oral and written communication skills.

Minimum Qualifications

• 2-4 years of relevant life sciences quality experience within quality and/or quality-related functions.
• Demonstrated track record with the successful support of GMP manufacturing and testing environments.
• Demonstrated quality experience and the ability to collaborate with and effectively influence others.
• Demonstrate experience with gowning and following aseptic behaviors.
• Experience with aseptic, cell therapy, and/or viral vector manufacturing.

Other Ideal Personal Characteristics

• Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Performs with Integrity.
• Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
• Experience in the application of lean methodologies and operational excellence to continuously improve.

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 $65,000.00 - $82,250.00. 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.