MSAT Data Specialist

Overview

In compliance with current good manufacturing practices, the MSAT Data Specialist is responsible for data acquisition, supporting data entry to the electronic database system, and maintaining the manufacturing database. This role will help to fill the substantial need for database management and process analytics capabilities.

Specific Responsibilities

• Coordinate and participate in entry and verification of large amounts of process and raw material data accurately and consistently from process Batch Records and other relevant source documents in collaboration with CMOs, QA, and Manufacturing Operations.
• Develop and maintain clear and concise procedures to ensure data integrity.
• Trend, and analyze process generated data; summarize findings in memos, reports, and presentations.
• Ensure maintenance of the MSAT database in collaboration with IT.
• Collaborate with process SMEs for continuous improvement of the MSAT database.
• Support MSAT database validation activities in collaboration with CSV as needed.
• Perform other related duties as assigned to meet the goals and objectives of the department and institution.

Education and Qualifications

• The ideal candidate has a Bachelor’s Degree in computer technology or related field with 1 years of relevant working experience in the healthcare or pharmaceutical setting
• Experience demonstrated such experiences in a similar role
• Ability to understand/learn and link biological operations, and process engineering concepts quickly
• Understanding the Code of Federal Regulations, good manufacturing practices for finished pharmaceuticals relevant to clinical/commercial process data
• Familiar with computer systems including database, spreadsheet, and word processing applications
• Demonstrated ability to gather, understand, and manipulate complex data from varying sources accurately and effectively.
• Excellent oral and written communication skills
• Possess organizational skills/flexibility/teamwork in order to effectively prioritize daily workload and consistent maintain compliance with procedure timelines
• Ability to focus on the task for long periods with extremely high level of attention to detail is essential

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 grasp with both hands, perform repetitious actions such as pinch with thumb and forefinger, turn with hand/ arm, and reach above shoulder height.
• Must be able to work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 20 pounds multiple times daily.

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 deadlines

Work Environment

This position will work in an office.

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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