Associate II, Quality Assurance

Resilience•East Norriton Township, PA

4d•Onsite

About The Position

Associate II, Quality Assurance will organize and execute aspects of GMP implementation at the East Norriton (PHL) manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing.

Requirements

Familiarity with electronic quality systems/software applications.
Familiarity with laboratory and manufacturing execution systems.
Working knowledge of GLP/GCP and GxP Regulatory requirements

Nice To Haves

B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
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.
Specific experience with aseptic, cell therapy and/or viral vector manufacturing strongly preferred.
Experience in preparation and participation in regulatory authority plant/site inspections.
Experience supporting biologics manufacturing preferred
Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
Excellent oral and written communication skills.
Performs with Integrity.
Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
Experience in application of lean methodologies and operational excellence to continuously improve.

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.
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