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Associate Quality Assurance Specialist
2 months ago
Overview
Iovance is seeking a highly motivated individual for the position of GMP Associate Quality Assurance Specialist at Iovance’s IOVA-A facility (700 Spring Garden St) located within American Red Cross in Philadelphia, PA. This position is responsible for the Quality Assurance documentation related activities in support of the manufacturing/testing operations and ensuring compliance to quality objectives and regulatory requirements. This individual will be responsible for overseeing lot release tracking, consistently updating lot tracking status, assisting in lot release paperwork, and any relevant GMP documentation in support of manufacturing/testing of irradiated peripheral blood mononuclear cells (iPBMCs).
Essential Functions and Responsibilities
- Perform QA Operation activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of iPBMC products.
- Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
- Maintenance of records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well
- Maintain executed manufacturing/testing documentation, as Maintain training records, as applicable.
- Ensures GDP is followed and adhered to throughout life of documentation.
- General administrative duties as specified by Iovance and its
- Other activities in support of GMP manufacturing and testing
- Support GDP investigations as needed.
Required Education, Skills, and Knowledge
- Bachelor's degree in life sciences discipline or equivalent
- Experience in an electronic document management system (eDMS)
- Must possess a high level of attention to detail.
- Strong computer, organizational, and compliance
- Quality mindset.
- Familiarity with GMP, Good Documentation Practices (GDP), Document Change Management, and FDA quality systems.
- Ability to work effectively on multiple projects simultaneously with some Interpersonal and communication skills, desirable.
Preferred Education, Skills, and Knowledge
- Master Control
- Experience with DocuSign.
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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
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 individual’s 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.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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