Quality Systems Specialist Contract

5 days ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Description

Overview

The Quality Systems Specialist has experience in Quality Systems, QA, or Compliance in Pharmaceutical and/or Biotechnology companies. This individual is responsible for maintaining Quality Systems at Iovance's manufacturing facility to ensure GMP compliance in accordance with country regulations and guidelines, as well as the company's policies and procedures. They are an innovative, self-sufficient, self-motivated, and experienced candidate who takes ownership and accountability for quality at the facility. The specialist will support and oversee Quality System activities including deviations, CAPAs, and change controls. In this position, one is growth-oriented, have a continuous improvement mindset, and is someone who is passionate about working with others in a complex, changing, and fast-paced environment.

Key Responsibilities

  • Maintain the electronic Quality Management System (eQMS), with emphasis on change control, deviation, Out of Specification, Out of Trend, and CAPA processes
  • Provide user support to the eQMS system users
  • Generate status reports and support tracking of change controls, deviations, LIRs, and CAPAs to ensure timely closures of records
  • Implement, enhance, and maintain QMS procedures and work instructions based on best practices or compliance requirements
  • Support continuous improvement activities to increase the efficiency and effectiveness of the QMS
  • Represent the Quality System and Compliance group in cross-functional projects where applicable
  • May participate in internal audits or regulatory inspections (e.g., prep room participant, runner, scribe, etc.)
  • Support training activities and back-up efforts for Quality Systems processes
  • Support management with other Quality System and Compliance related tasks
  • 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.

Requirements

  • BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 3+ years of relevant experience
  • Current and working knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
  • Must be comfortable in a fast-paced environment with minimal direction and changing priorities
  • Strong interpersonal skills and ability to work collaboratively with colleagues cross-functionally
  • Strong computer skills including MS Office (Word, Excel, PowerPoint)

Preferred Qualifications

  • Experience with an electronic QMS, MasterControl preferred

Work Environment

  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

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