Associate II, Quality Assurance

A career at Resilience is an opportunity to change the future by organizing and executing aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP and build strong relationships with CMC/Operations/Development teams to ensure manufacturing and testing operations comply with all US and International regulatory expectations.

Requirements

• Work collaboratively with internal stakeholders and 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 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.
• Execute deviations, change controls and/or CAPAs, and other quality records, as needed.
• Create and approver manufacturing batch for execution within the electronic batch record.
• Review batches manufactured at East Norriton site.
• Review and approve executed environmental monitoring documentation at the East Norriton site.
• Author, review, and/or approve technical documents including but not limited to SOPs, various quality reports and assessments, as needed.
• Perform Facility change overs and Line clearances.
• Issuance of product labels.
• Release of GMP materials utilized in the manufacturing process, as needed
• Support in the packaging and shipment of drug materials.
• Execute documentation required to support disruptions to controlled environments, as needed.
• Manages client communications, escalations, and documentation, as needed.
• Supports audits/inspections for the East Norriton site, as needed.
• Trains Quality Associates in the QA Operations Team and other departments, as needed.
• Completes qualified program requirements necessary to train other employees.
• Support Quality Assurance team members, as needed

Benefits

• Annual cash bonus program
• 401(k) plan with a generous company match
• Healthcare (including medical, dental and vision)
• Family building benefits
• Life and disability insurance
• Paid vacation
• Paid holidays
• Other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs