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Quality Assurance Lead Specialist
2 months ago
Position Overview
The Senior Quality Control Lead - Microbiology will oversee quality assurance testing operations at Iovance Biotherapeutics Inc. This role encompasses in-process and final product microbial assessments, bioburden evaluations, endotoxin testing, mycoplasma analysis, gram staining, environmental surveillance, and sterility procedures. The position requires flexibility to work across various shifts, including weekends and overtime as necessary.
Work Schedule: Monday to Friday, 8 AM - 5 PM
Key Responsibilities
- Conduct cGMP quality control laboratory microbiological assessments at the designated facility.
- Facilitate Gowning and Environmental Monitoring Training sessions.
- Deliver laboratory training, author technical documentation, and lead the technical writing process.
- Initiate efficiency enhancement projects and assist in investigations related to out-of-specification test outcomes.
- Provide subject matter expertise, review technical documents, and perform comprehensive data analysis.
- Ensure adherence to cGMP compliance, safety protocols, and organizational core values.
- Participate in cross-functional team meetings and mentor new staff members.
- Exhibit attention to detail, effectively manage competing priorities, and demonstrate high levels of productivity.
Qualifications and Skills Required
- Master's degree is preferred.
- Bachelor's degree in biological sciences or a related field.
- A minimum of 7 years of quality control experience within the pharmaceutical sector.
- Robust background in technical writing and method validation.
- Proven ability to collaborate with multidisciplinary teams and exceptional technical capabilities.
Physical Requirements
- Ability to wear cleanroom attire and personal protective equipment, meeting physical demands.
- Capability to utilize near vision, lift up to 45 pounds, and perform repetitive tasks.
Mental Requirements
- Strong judgment, problem-solving skills, and the ability to manage work-related stress effectively.
Work Environment
- Combination of office and laboratory settings, with exposure to chemical and biochemical substances.
- Potential exposure to noise, equipment hazards, and odors.
- Work in a cleanroom environment with biohazards and human blood components.
Iovance Biotherapeutics Inc. is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and consider all applicants without discrimination. For accommodation requests, please contact Human Resources.
