Lead Quality Control Specialist - Microbiology

Overview

The Lead Quality Control Analyst - 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 and validation 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.

Work shift: Mon-Fri 8AM-5PM

Essential Functions And Responsibilities

• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
• Support Gowning and Environmental monitoring Training and Qualifications.
• Perform environmental monitoring of the cleanroom areas as scheduled.
• Possesses and applies comprehensive knowledge of microbiology testing and Environmental monitoring to the completion of complex assignments like supporting validation studies.
• Operate at a consistent and exemplary level of efficiency, producing high quality accurate results.
• Conducts training on laboratory and Quality Control protocols.
• Authors and leads technical documents, such as test methods, operating procedures and work instructions for LIMS.
• Review technical documents for accuracy, update the SOPs per Change controls, thoroughness, and regulatory compliance.
• Train, Coach and Mentor other analysts on technical and testing issues.
• Develop and execute efficiency improvement projects.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Perform all activities for cGMP compliance.
• Support thorough cGMP investigations for out-of-specification test results.
• Support technical problem-solving.
• Support product stability programs, including execution of stability testing, stability data analysis, 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
• Perform peer review of laboratory data and logbooks.
• Provide input to functional laboratory and cross functional team meetings.
• Act as subject matter expert (SME) on one or more assays and train new laboratory personnel.
• Solid understanding and functional knowledge with hands on experience with the following: environmental monitoring, endotoxins, sterility, growth promotion, and mycoplasma.
• Proficient in performing technical writing (e.g., test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.)
• Extremely detail oriented
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Supports supervision with scheduling staff as needed.
• Support inspections as needed.
• Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
• Work in a cleanroom with biohazards, human blood components, and chemicals
• 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.
  
  

Required Education, Skills, And Knowledge

• Master’s degree preferred.
• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum 7 years of experience in the pharmaceutical industry within a Quality Control role with experience in method transfers, Change controls and Method validation.
• Strong background in technical writing, drafting reports and SOPs.
• 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.
  
  

Preferred Education, Skills, And Knowledge

• 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 accommodation.

Physical Demands And Activities Required

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a day 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 with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.
  
  

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
  
  

Work Environment

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.
  
  

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s 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, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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