Senior Quality Release Specialist - Nights-Wednesday to Saturday - 9pm-8am

About the position

The Senior Quality Release Specialist will support review of documentation and support releasing of materials and products. The Sr Quality Release Specialist will also ensure compliance to Iovance procedures by supporting lot closure and deviation reviews. This position operates on a night shift from 9PM to 8AM.

Responsibilities

• Ensure compliance to cGMPs and facility procedures.
• Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition.
• Collaborate with internal functions to address all identified issues in a timely manner.
• Determine if the issue needs to be documented in the Quality System.
• Coordinating release tasks as assigned to the Quality Release team by the schedule.
• Collaborating lot release dates with cross functional teams for clinical release.
• Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
• Perform disposition of incoming materials and finished product.
• Initiate and review of documentation for release.
• Issuance of labels.
• Support generation of Quality Metrics.
• Ensure timely lot closure.
• Support and review deviations, CAPAs, Laboratory Investigations, temperature excursions and other non-conformances.
• Perform miscellaneous duties as assigned.

Requirements

• A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience; or equivalent experience.
• At least five years of experience in a regulated industry.
• Proficient knowledge of cGMP regulations.
• Perform routine activities with minimal oversights.
• Prior experience with review of QC data specific to cell therapy testing.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Extremely detail oriented with strong technical skills.
• Knowledge of MasterControl is preferred.
• High level of accountability and ownership.
• Demonstrate a sense of urgency ability to recognize time sensitivity.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multidisciplined teams.

Nice-to-haves

• Knowledge of QMS systems is a plus.