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Quality Control Analytical Specialist
2 months ago
Position Overview
The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, validation of methods and instruments, and technical transfers pertinent to Analytical and/or Microbiological quality assurance testing of products, raw materials, and packaging components. This role also involves the operation and maintenance of quality control instruments in accordance with cGMP/FDA regulations and company standard operating procedures.
Work Schedule
Shift: Sunday - Thursday from 8:30am - 5:00pm
Key Responsibilities
- Conducts testing for method and instrument implementation and qualification/validation protocols.
- Assists in investigational testing for Phase II LIR OOS/OOT.
- Ensures timely completion of essential tasks, including SOPs, aseptic techniques, gowning, testing, and EHS compliance.
- Prepares necessary documentation, forms, and records, such as method or instrument qualification/validation records, adhering to Good Documentation Practices.
- Supports internal and external audits and inspections as required.
- Upholds the core values, policies, procedures, and business ethics of Iovance Biotherapeutics.
- Performs additional duties as assigned.
Required Qualifications
- Bachelor's degree in biology, Biochemistry, Microbiology, Chemistry, or a related scientific discipline with 1-3 years of GMP experience.
- Strong understanding and practical experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
- Proficient in technical writing, including test methods, SOPs, and protocols.
- Ability to collaborate effectively with multi-disciplinary teams.
- Detail-oriented with robust technical skills.
- Capable of managing multiple priorities with high productivity.
- Demonstrates a strong sense of ownership and accountability.
- Exhibits urgency and recognizes time-sensitive tasks.
- Proficient in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Preferred Qualifications
- Master's degree with four years of relevant experience.
- Experience with cell therapy products is advantageous.
Physical Requirements
The physical demands of this position include the ability to wear appropriate Personal Protective Equipment (PPE), work in a laboratory environment with biohazards and various chemicals, and perform physical activities such as standing, walking, bending, and lifting objects up to 45 pounds.
Mental Requirements
This role requires clear and conceptual thinking abilities, excellent judgment, problem-solving skills, and the capacity to manage work-related stress while meeting deadlines.
Work Environment
The position involves working in both an office and laboratory setting, with potential exposure to hazardous or biological waste.
Diversity and Inclusion
Iovance is dedicated to fostering a diverse and inclusive workplace. We are an equal-opportunity employer, and all employees and applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.
