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GMP Associate

Exton, PA 19353

Posted: 04/16/2025 Employment Type: Contract To Hire Job Category: Manufacturing Job Number: 618557 Is job remote?: No Country: United States

Job Description

A late-stage, gene therapy company, headquartered in Pennsylvania 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Exton, PA

Ready to discover your dream job in Exton, Pennsylvania? This vibrant town in Chester County, just a short drive from Philadelphia and Wilmington, offers a perfect blend of small-town charm and big-city opportunities. With a thriving job market and proximity to major highways like Route 30 and the Pennsylvania Turnpike, Exton provides easy access to top employers, fantastic dining options like the Exton Square Mall, fascinating art galleries, and great cultural attractions like the People's Light theater. Whether you're into outdoor activities at Marsh Creek State Park or rooting for the Philadelphia Union soccer team at Subaru Park, Exton has something for everyone. Explore our job listings today and kickstart your career in this captivating region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.