Quality Control Analyst I - Microbiology [Contract to Hire]

at  Iovance Biotherapeutics Inc

OVERVIEW

The Quality Control Analyst I- Microbiology will support quality control testing operations at Iovance’s Cell Therapy Center (iCTC) and/or iPBMC manufacturing site (IOVA-A). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to complete assigned work.

REQUIRED EDUCATION, SKILLS, AND KNOWLEDGE

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• 0-4 years of experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.
• 0-1 year of EM is required.
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

PREFERRED EDUCATION, SKILLS, AND KNOWLEDGE

• Advanced degree (MSc. preferred.)
• Previous experience with GDP, GLP, GMP is preferred.
• Experience with cell therapy products is a plus.
  The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform environmental monitoring of the cleanroom areas as scheduled.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Support technical problem-solving for issues pertaining to GMP Quality Control
• Support product stability programs, including execution of stability testing, stability data analysis and trending, and final reporting of stability data.
• Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls
• Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.