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Manufacturing Operations Support Specialist

2 months ago


Columbia, South Carolina, United States CARsgen Therapeutics Full time

Position Overview:

The Manufacturing Support Associate I plays a vital role in assisting with the production of cellular drug therapies in a regulated GMP environment. This position works under the guidance of supervisory staff and adheres to established company policies and industry regulations. The role encompasses various support functions essential for the manufacturing of CAR-T products, including cleaning, inventory management, and documentation assistance.

  1. Key Responsibilities:
  2. Conduct scheduled support tasks in accordance with cGMP standards.
  3. Draft, update, and assess Standard Operating Procedures (SOPs).
  4. Ensure adherence to documentation protocols and operational procedures.
  5. Coordinate and execute cleaning operations within cleanroom environments.
  6. Review daily documentation to verify compliance before the conclusion of shifts.
  7. Assist in the coordination of materials necessary for manufacturing processes.
  8. Apply aseptic techniques as required.
  9. Participate in the cleaning program for manufacturing equipment and ensure that all critical environments are maintained according to validated methods.
  10. Contribute to the documentation and investigation of non-conformances, deviations, and Corrective and Preventive Actions (CAPAs).
  11. Required Qualifications:
  12. Experience in a cGMP environment is preferred.
  13. Strong verbal and written communication skills.
  14. Ability to effectively implement protocols and procedures.
  15. Physical capability to lift, push, and pull items weighing up to 25 lbs.
  16. Capacity to stand for extended periods.
  17. Ability to don appropriate cleanroom attire for manufacturing tasks.
  18. Familiarity with cGMP documentation and practices.
  19. Basic proficiency in computer applications (email, word processing, spreadsheets).
  20. High ethical standards with a commitment to confidentiality and professional sensitivity.
  21. Excellent organizational, time management, and communication skills.
  22. Ability to perform physical tasks requiring dexterity and mobility, including routine walking and occasional lifting of heavy materials.