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Quality Assurance Training Specialist
2 months ago
Salary: Competitive
Company Overview:
Iovance Biotherapeutics is a dynamic and innovative organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. We are seeking a Quality Control Training Specialist to enhance our quality control training initiatives at the integrated Cell Therapy Center (iCTC).
Role Summary:
The Quality Control Training Specialist will be responsible for developing and implementing training programs that encompass various aspects of quality control, including in-process testing, final product evaluation, and stability assessments, specifically focusing on cell therapy products.
Key Responsibilities:
- Serve as a subject matter expert (SME) and mentor for new laboratory staff.
- Conduct training sessions on cell count determination (NC-200), immunophenotyping via flow cytometry (BD FACSLyric), and cell-based potency assays using diverse immunoassay platforms.
- Ensure all activities comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Perform GMP Quality Control laboratory testing at the iCTC facility, ensuring adherence to all relevant procedures and regulations.
- Assist in comprehensive GMP investigations for out-of-specification results and other quality-related incidents.
- Support technical troubleshooting for GMP Quality Control challenges.
- Contribute to product stability programs, including the execution of stability tests and final reporting of results.
- Participate in the creation, revision, and review of essential documentation such as Standard Operating Procedures (SOPs), protocols, and reports.
- Initiate and manage quality documents, including deviations, laboratory investigations, Corrective and Preventive Actions (CAPAs), and change controls.
- Conduct technical reviews of laboratory data and logbooks.
- Maintain a high level of efficiency and accuracy in all tasks.
- Assist during Health Authority inspections.
- Provide valuable input during functional laboratory team meetings.
- Adhere to Iovance Biotherapeutics' core values, policies, and ethical standards.
- Comply with safety protocols and laboratory procedures in accordance with company policies and OSHA regulations.
- Perform additional responsibilities as assigned.
Qualifications:
- Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or a related scientific discipline, or an equivalent combination of education and experience.
- A minimum of three (3) years of GMP experience in the pharmaceutical sector within a Quality Control capacity.
- Proficient understanding and hands-on experience in at least two (2) of the following areas: Multicolor Flow Cytometry, Cell-based ELISA, and cell culture with enumeration (NC-200).
- Experience in technical documentation, including test methods, SOPs, protocols, deviations, and CAPAs.
- Ability to manage multiple priorities effectively while maintaining high productivity levels.
- Strong collaboration skills to interface with cross-functional teams.
- Detail-oriented with exceptional technical capabilities.
- Demonstrated sense of urgency and accountability.
- Proficient in Microsoft Office Suite (Outlook, Excel, Word, PowerPoint).
Preferred Qualifications:
- Experience with cell therapy products and relevant technical skills (NC 200, ELISA, and/or Flow) is advantageous.
Physical Requirements:
- Must be able to wear appropriate Personal Protective Equipment (PPE) as required.
- Ability to stand and/or walk for 90% of the workday, with occasional lifting of objects weighing up to 20 pounds.
- Capable of performing tasks that require near vision and repetitive motions.
Mental Requirements:
Strong analytical and problem-solving skills, with the ability to manage work-related stress and prioritize multiple tasks effectively.
Work Environment:
This position involves working in both an office and laboratory setting, with potential exposure to various chemicals and laboratory hazards.
Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and consider all applicants without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.
