Associate Ii, Quality Assurance

• Escalate any events occurring on the manufacturing floor to Management.
• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
• Review deviations, change controls, and/or CAPAs, as needed.
• Perform Facility changeovers and Line clearances.
• Release of GMP materials utilized in the manufacturing process as needed.
• Issuance of product labels, as needed.
• Maintain a presence of Quality Assurance on the manufacturing floor during GMP runs to ensure compliance to GMPs.
• 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.
• 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.

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

• Experience with aseptic, cell therapy, and/or viral vector manufacturing.
• 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.
• Demonstrate experience with gowning and following aseptic behaviors.
• Demonstrated quality experience and the ability to collaborate with and effectively influence others.

• Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
• Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Performs with Integrity.
• 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.