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Microbiology Quality Assurance Training Specialist
2 months ago
Iovance Biotherapeutics, Inc. is an innovative and expanding organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. The role of the Quality Control Training Specialist is pivotal in facilitating quality control training at our integrated Cell Therapy Center (iCTC).
The Quality Control training initiatives encompass various aspects, including in-process, final drug product, and stability assessments, with a particular emphasis on cell therapy products.
The Quality Control Training Specialist, Microbiology will be responsible for enhancing quality control microbiology and environmental monitoring training at the iCTC and/or the iPBMC manufacturing site. The training programs will cover critical areas such as microbial testing for bioburden, endotoxins, mycoplasma, gram staining, environmental monitoring, and sterility techniques. This position may require flexibility in working hours, including weekends and holidays, to fulfill operational needs.
Key Responsibilities:
- Serve as a subject matter expert (SME) and mentor new laboratory personnel.
- Conduct training sessions on environmental monitoring of cleanroom environments and growth promotion of microbiological media.
- Lead educational sessions for Grade B gowning, perform gowning qualifications, and oversee annual gowning assessments.
- Instruct staff on gram staining, endotoxin testing, sterility assessments, and mycoplasma testing.
- Assist in troubleshooting technical issues related to GMP Quality Control.
- Contribute to the creation and revision of documentation, including SOPs, protocols, reports, deviations, laboratory investigations, CAPAs, and change controls.
- As necessary, conduct GMP Quality Control laboratory testing and environmental monitoring at the iCTC facility, ensuring compliance with all relevant procedures, standards, and GMP regulations.
- Perform peer reviews of laboratory data and logbooks.
- Provide insights during functional laboratory and cross-functional team meetings.
- Maintain a high level of efficiency and accuracy in producing quality results.
- Adhere to the core values, policies, procedures, and ethical standards of Iovance Biotherapeutics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures as per company policy and OSHA regulations.
- Carry out additional duties as assigned.
Required Qualifications:
- Bachelor's degree in a relevant field (biological sciences or equivalent).
- A minimum of three (3) years of experience in the pharmaceutical sector within a Quality Control capacity.
- Proven ability to develop training materials, conduct training sessions, and assess training program effectiveness.
- Ability to collaborate effectively with multidisciplinary teams.
- Meticulous attention to detail with strong technical skills.
- Capability to manage multiple priorities with aggressive timelines while maintaining high productivity.
- Demonstrated ownership and accountability.
- Ability to recognize and respond to time-sensitive situations.
- Previous experience with GDP, GLP, and GMP practices.
- Excellent written and verbal communication skills for creating training documentation and effectively guiding trainees.
Preferred Qualifications:
- Advanced degree (MSc. preferred).
- Experience with cell therapy products is advantageous.
Physical and Mental Demands:
The physical demands outlined here represent those that an employee must meet to successfully perform the essential functions of this role. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE).
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk for 90% of the workday, which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities involving repetitive motions.
- Must be able to lift and carry objects weighing up to 45 pounds.
Work Environment:
This position will operate in both an office and a manufacturing laboratory setting. In the lab, there may be exposure to various chemical and biochemical substances, including latex and bleach, as well as potential variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. The role requires working in a cleanroom environment with biohazards, human blood components, and chemicals.
Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal-opportunity employer, we consider all employees and applicants without regard to 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, or any other characteristic protected by applicable law.
