Job Description

• Location: Exton, PA
• 3-6-month contract to hire
• Salary: $60-70K + 12% bonus (based on company and individual performance)
• Strong documentation experience is a must.
• Full-time (40 hours/week) but eligible for overtime.

A late-stage, gene therapy company is looking to add two (2) GMP Associates to its growing team. In this role you will perform a variety of tasks in support of daily production of sterile cell-based gene therapy product. Operations are predominately preformed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.

Experience:

• High School Diploma, or equivalent with 1- 3 years’ relevant industry experience.
• Must be comfortable with performing tasks while fully gowned in a cleanroom environment.
• Familiar with 21 CFR Part 11, standard GxP best practices and FDA regulations.
• Must be willing to work weekends, evenings, and holidays (as needed).

Responsibilities:

• Perform daily room cleaning and disinfection tasks within the controlled and supporting areas, including the aseptic cleanrooms.
• Ability to follow batch records, SOP’s and other cGMP documentation.
• Records, enters, and verifies data appropriately in relevant documentation and databases in a clear and concise manner per Good Documentation Practices (GDP).
• Provide operational support for manufacturing activities including but not limited to the following: critical reagent warming and thawing, material inventory, kit preparation, equipment maintenance, final product transfers, audit preparedness, etc.
• Ensure adequate inventory of supplies and raw materials are stocked in the controlled and supporting areas.
• Assists with warehouse management, critical reagents inventory, and the maintenance of material inventory logs.
• Completes and documents all applicable training in a timely fashion; ensures training status remains in good standing.
• Completes action items and necessary tasks to aid in the closure of outstanding quality items (i.e. deviations, investigations, change controls, etc.).
• Perform basic document revisions as needed to accurately reflect current procedures.
• Identifies and escalates atypical observations or issues to area management in real time.

Computer Skills: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software.

• Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands and fingers to handle equipment or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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