DUTIES: Support day-to-day quality assurance oversight of the GMP manufacturing and quality control testing of purified iPBMCs which serve as an essential critical raw material in the TIL drug product manufacturing process. Responsible for assessing GMP compliance to Food, Drug, and Cosmetics Act regulations through release of raw materials and components for use, controlled document and label issuance, facilities audits and inspections, aseptic process observations, good documentation review, anomaly investigations, data conformance, and product disposition. Prepare and organize release documentation in support of lot disposition, ensure GDP, maintain high level of quality on site, and other duties as required.
May be assigned to various, unanticipated sites throughout the United States.
REQUIRED: Education: A Master's degree in in a pharmaceutical or life sciences field. Experience: At least one year in position offered or in a QA role, in the pharmaceutical industry. Skills: GMPs; QA work involving deviation of CAPAs, change control, laboratory investigations/OOS/OOT; manufacturing of Sterile Drug substances and Drug Products; QA oversight of QC testing; QA release of raw materials in GMP compliant manner; use of GDP [review of QC in-process and release testing records, review of environmental monitoring data, laboratory investigations, method validations, deviations, change controls, and CAPAs]; support internal audits and regulatory inspections; eDMS, MasterControl and MES. Hiring requirement: background checks
SALARY RANGE: $125,000 - $136,000 per year
BENEFITS & COMPENSATION: Medical/dental/vision/income protection plans; HSA ; paid time off & parental leave; EAP; wellness programs; legal & identity theft insurance; 401(k); stock purchase plan; professional development; annual cash bonuses & long-term incentives.
To apply, email resume to careers@iovance.com and include "Quality Assurance Specialist (GMP/TIL) role" in the subject line
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