Quality Control Specialist I, Compliance. Days-Wednesday to Saturday-9am-8pm (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 Compliance Analyst who will be responsible for the generation of internal and external Certificates of Analysis (CoA) for the Quality Control Department. This role will support the release of final product, supporting external manufacturing and Quality Control documentation and data management. This role will also be responsible for creating departmental procedures, strategic planning, and deploying process efficiencies. The Quality Control Compliance Specialist must have a good understanding of cGMP quality records, QC testing/LIMS and quality metrics.

Schedule: Wednesday to Saturday from 9am-8pm. 

Essential Functions and Responsibilities

• Creates QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support the release of final products, both internally and externally.
• Maintaining lot lifecycles in LIMS by logging in batches, entering data, reviewing data and batches.
• Performing Quality Control documentation and data management, including issuing testing forms and data storage.
• Assist with tracking the status of quality records within QC to ensure on-time closure.
• Escalates roadblocks to completion of records and provides potential solutions.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• 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; experience with cell and/or gene therapy products is a plus.
• Successfully interface with multi-disciplined teams in a global setting. 
• 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.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation 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 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 onsite in both an office and a manufacturing setting.
• Potential exposure to noise, equipment hazards and strong odors.

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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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