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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 the production of cellular drug therapies within a Good Manufacturing Practice (GMP) environment. This position works closely with supervisory staff to ensure that all support functions are executed in accordance with established regulations and company standards.

Key Responsibilities:

  1. Conduct scheduled support tasks in compliance with cGMP guidelines.
  2. Draft, amend, and evaluate Standard Operating Procedures (SOPs).
  3. Guarantee adherence to documentation and procedural requirements.
  4. Coordinate and execute cleaning operations within the cleanroom environment.
  5. Review daily documentation to confirm compliance before the conclusion of each shift.
  6. Facilitate material coordination activities essential for manufacturing processes.
  7. Utilize aseptic techniques as required.
  8. Participate in the cleaning program for manufacturing equipment, ensuring all critical environments are maintained according to validated methods.
  9. Assist in the documentation and investigation of non-conformances, deviations, and Corrective and Preventive Actions (CAPAs).

Qualifications:

  • Experience in a cGMP setting is preferred.
  • Strong verbal and written communication skills.
  • Ability to effectively implement protocols and procedures.
  • Physical capability to lift, push, and pull up to 25 lbs.
  • Capacity to stand for extended periods.
  • Ability to properly gown for cleanroom operations.
  • Familiarity with cGMP documentation and practices.
  • Basic proficiency in computer applications (email, word processing, spreadsheets).
  • Demonstrated ethical standards and professionalism, with a commitment to confidentiality.
  • Excellent organizational, time management, and communication skills.
  • Ability to perform physical tasks requiring dexterity and mobility, including routine walking and occasional lifting of heavy materials.