Position Summary:
Working closely with supervision, Manufacturing Support Assistant contributes to support functions for manufacture of cellular drug therapies within a GMP setting. Operates under current regulations and company policies. Participates in all support operations for the manufacturing CAR-T products including but not limited to cleaning, stocking, and document support.
Responsibilities:
- Perform scheduled support activities per cGMP.
- Write, revise, and review SOPs.
- Ensures compliance with documentation and procedures.
- Perform and coordinate cleanroom cleaning operations.
- Review documentation daily to ensure compliance prior to end of shift.
- Perform material coordination activities for manufacturing.
- Application of aseptic techniques.
- As required, participate in the manufacturing equipment cleaning program and work to assure all critical environments are maintained per qualified methods.
- Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.
Qualifications:
- cGMP experience preferred.
- Excellent verbal/written communication skills.
- Effectively execute protocols, procedures.
- Physical ability to push, pull and lift up to 25 lbs.
- Physical ability to stand long periods.
- Ability to gown appropriately for cleanroom manufacturing.
- Understanding of cGMP documentation and practices.
- Basic computer knowledge (emails, word, excel).
- Highly ethical and transparent with professional sensitivity and care with confidentiality.
- Strong communication, written and verbal and strong organizational and time management skills.
- Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials