What are the responsibilities and job description for the Senior Quality Release Specialist - Wednesday to Saturday - 2pm-1am position at Iovance Biotherapeutics Inc?
Job Description
Job Description
Salary : Overview
The Senior Quality Release Specialist will support review of documentation and support releasing of materials and products. Th Sr Quality Release Specialist will also ensure compliance to Iovance procedures by supporting lot closure and deviation reviews.
Shift : Wednesday to Saturday from 2 : 00pm-1 : 00am
Essential Functions and 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.
Required Education, Skills, and Knowledge
Preferred Education, Skills, and Knowledge
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
Mental : Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical / biochemical is possible. Requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individuals race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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