Sr. Quality Assurance Specialist Ii

• Understand risks and delays to batch release and communicate appropriately.
• Review documentation for manufacturing activities including but not limited to executed batch records and master batch records.
• Releases batches manufactured at East Norriton.
• Reviews and approves the certificate of analysis.
• Mentor, coach, and train Quality Associates in the QA Operations Team.
• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
• Compile and report performance metrics for batch review and release.
• 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.
• Review deviations, OOSs, change controls and/or CAPAs, as needed.
• Author and review technical documents including but not limited to SOPs, risk assessments, various quality reports.
• Independently performs batch record review.

• Working knowledge of GLP/GCP and GxP Regulatory requirements.
• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• Familiarity with electronic laboratory and manufacturing execution systems.
• Familiarity with electronic quality systems/software applications.
• Experience in preparation and participation in regulatory authority plant/site inspections.
• Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Demonstrated quality experience and the ability to collaborate with and effectively influence others.

• Experience supporting biologics manufacturing.
• Experience with a quality batch review and batch release.
• 7-10 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.
• Experience with aseptic, cell therapy and/or viral vector manufacturing is strongly preferred.

• Excellent oral and written communication skills.
• Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
• 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.
• Performs with Integrity.

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 $95,000.00 - $132,500.00. 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.