Data Review Analyst, Quality Control Microbiology [Contract]

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  Iovance is seeking a Quality Control MicrobiologyData Review Analyst who will be responsible for timely review of Microbiology and Environmental monitoring testing data for the Quality Control Department. This role will support the release of final product, supporting internal and external manufacturing. The Quality ControlData Review Analyst must have a good understanding of Good Documentation Practices, cGMP quality records, QC testing/LIMS and quality metrics.

Essential Functions and Responsibilities:

• Reviews QC Microbiology testing of finished products, and consumable materials, following all written procedures and cGMP, and providing assurance of accurate documentation of analyses
• Conducts and writes laboratory investigations, with support from the Manager
• Verifies appropriate documentation for environmental monitoring, sterility testing, gram stain, and endotoxin testing.
• Documents completion of review and approval of data in the appropriate laboratory systems
• Reports any issues to the Supervisor upon discovery.
• Track the status of Quality Control records to ensure on-time review for QC records.
• Assist with updating metrics on departmental performance of quality records and gives oral presentations to stakeholders.
• Escalates roadblocks to completion of Data Review and provides potential solutions.

Basic Qualifications:

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve them.

Preferred Qualifications:

• Experience with cell and/or gene therapy products

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 remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

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
• Ability to meet deadlines

Work Environment:

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, 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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