Senior Quality Assurance Specialist

11 hours ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Title: Senior Quality Assurance Specialist

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. This role will play a critical part in ensuring the quality and regulatory compliance of our commercial and clinical products.

Key Responsibilities:
  • Represent Iovance QA by working on-site at the Contract Manufacturing Organization (CMO) for up to 5 days per week.
  • Support CMO manufacturing, testing, and release activity on weekends, as needed.
  • Establish direct lines of communication with the CMO QA functions.
  • Review and approve master and executed batch records for manufacturing, testing, and release of raw materials and finished products.
  • Participate in review of investigations and deviations.
  • Release or reject clinical lots and issue appropriate release certificates.
  • Maintain batch record files and associated documentation.
  • Develop or review Standard Operating Procedures (SOPs) required for supporting system change or enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements.
  • Support or represent Quality in creation and presentation of Quality management review metrics as necessary.
  • Interface and support management of CMOs as needed.
  • Support other quality systems and operations activities as requested.
  • Support in regulatory inspection and inspection readiness activities.
Requirements:
  • Bachelor's degree in a life sciences discipline or equivalent.
  • 5+ years of biopharmaceutical industry experience.
  • Direct experience with review of clinical manufacturing documentation and release of clinical product.
  • Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.
  • Ability to follow through on all activities to ensure projects are completed as planned.
  • Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities.
  • Demonstrated ability to collaborate and influence across the organization to gain support and commitment for team goals.
  • Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders.
  • Ability to meet deadlines and multitask efficiently; willing to work a flexible schedule.
  • Proficient with the Microsoft Office Suite, including Word, Excel, PowerPoint, and Project.
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 a lab setting with various chemical and biochemical exposures, including latex and bleach.
  • Able to work in a cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

Iovance Biotherapeutics Inc 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 us.

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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