Quality Assurance Specialist

USWM, LLC•Philadelphia, PA

10d

About The Position

The 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 2 years in a biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
Familiarity with review and approval of batch records
Knowledge of aseptic processing and aseptic gowning techniques
Ability to qualify in aseptic gowning; prior experience in aseptic gowning preferred
Knowledge of GMP, ICH and FDA/EMA regulations
Knowledge of Quality Systems, such as Change Control, Investigations, and CAPA

Responsibilities

Conduct record review of executed batch records 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