Quality Control Analyst I- Microbiology Contract to Hire Night Shift

Overview

The Quality Control Analyst I Microbiology will support quality control testing operations at Iovances
Cell Therapy Center (iCTC) and/or iPBMC manufacturing site (IOVAA). The quality control testing
programs include inprocess 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.

Shift: Wednesday to Saturday Night Shift from 7pm to 6am.

Essential Functions and Responsibilities
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 problemsolving for issues pertaining to GMP Quality Control
Support product stability programs including 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 highquality 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.

Required Education Skills and Knowledge

Bachelors degree in a relevant discipline (biological sciences or equivalent)
04 years of experience in the pharmaceutical industry within a Quality Control role; experience with
cell therapy products is a plus.
Successfully interface with multidisciplined teams
Extremely detailoriented 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.

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 halfface respirator.
Able to stand and/or walk 90 (and sit 10 of the scheduled 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 with repetitive motions.
Must be able to lift and carry objects weighing 45 pounds.

Mental:

Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and
discretion; ability to handle workrelated 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 setting. When in the lab you may be exposed
to various chemicals/biochemical including latex and bleach. Additionally there is potential for variable
noise levels equipment hazards strong odors and other detergents/sanitizers. 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 individuals 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.
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