Sr Quality Assurance Specialist

USWM, LLC • Philadelphia, PA

1d

About The Position

The Senior Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release, support shipments and facilitating timely release of production lots for Tecelra and other clinical products. The successful candidate will work closely with other Quality groups, Quality Control and Manufacturing to identify strategies, tactics and objectives for product quality and GMP compliance.

Requirements

• Bachelor’s Degree in a scientific discipline.
• Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
• Direct experience with review and approval of batch records and QC testing data
• Knowledge of aseptic processing and aseptic gowning techniques
• Broad knowledge of GMP, ICH and FDA/EMA regulations
• Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
• Ability to work on assigned projects independently with limited supervision

Responsibilities

• Conduct record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots.
• Perform disposition of lentiviral vector and finished drug product batches.
• Liaise with external CMO and contract Qualified Persons in support of manufacture and release of lentiviral vector or T-cell drug product for US, EU and UK use
• Performs line/room clearance to support manufacturing activities in aseptic suites
• Print, issue and reconcile production labels, QC labels and final product labels
• Inspect, review and release raw materials and consumables for GMP use
• Provide QA oversight of incoming and outgoing shipments of apheresis, lentiviral vector, or finished T-cell drug product
• Manage Deviation, CAPA or Change Control records related to Quality Assurance operations
• Create or revise Quality SOPs
• Occasional weekend work required
• Other responsibilities as required

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees