What are the responsibilities and job description for the Senior Quality Operations Specialist - Sunday to Wednesday 7am 6pm position at Iovance Biotherapeutics Inc?
Job Description
Job Description
Salary : Overview
The Senior Quality Operations Specialist is responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures, and will support review of deviations, investigations, protocols to support the release of materials and products.
This individual will be responsible for supporting day-to-day Quality Operations activities relating to support manufacturing and the release of products manufactured at iCTC. The individual will be collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.
Essential Functions and Responsibilities :
- Perform real-time, on-the-floor support for escalations to ensure compliance with GMP,GDP, 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 escalate to management.
- Support the schedule and coordinate daily activities ensuring conformance to the daily schedule.
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content,quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
- Review executed documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
- Issuance of lot numbers and supporting documentation as needed for the shift.
- Support release of drug products and materials.
- Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
- Review of Quality System records for compliance.
- Work in a cleanroom with biohazards, human blood components, and chemicals.
- Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Education and Qualifications
Physical Requirements :
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
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 position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals / biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents / sanitizers.
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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the positions duties 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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