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Environmental Monitoring Quality Control Specialist

2 months ago

Spring, Texas, United States Cellipont Bioservices Full time
Job Summary

Cellipont Bioservices is seeking a highly skilled Environmental Monitoring Quality Control Specialist to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the highest standards of quality and safety in our manufacturing processes.

Key Responsibilities
  • Perform routine Environmental Monitoring of Grades A-D Cleanroom environment, including sampling of viable surfaces, viable air, and non-viable particulates in a GMP Manufacturing facility.
  • Conduct Environmental Monitoring Performance Qualifications (EMPQ) of cleanrooms.
  • Perform and assist with growth promotion, sterility, endotoxin, and mycoplasma testing.
  • Assist in the performance of Aseptic Process Simulations (media fills) and fill/finish monitoring, including continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
  • Support Gown Qualifications.
  • Effectively communicate results of own work through discussions and documentation with some input from supervisor.
  • Flexibility in following unique campaign requirements that may include off-hour and weekend work.
  • Assist in inventory management and cost effectiveness for the department.
  • Ability to cross-train into other streams of Quality Control.
Requirements
  • Bachelor's Degree in Life Sciences preferred with 0-1 years of relevant industry experience.
  • Creative individual with outstanding trouble-shooting skills.
  • Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor.
  • Experience working in cGMP Quality Control is a plus.
  • Experience with Microsoft Office.
  • Knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
What We Offer
  • Opportunities for career growth within an expanding team.
  • Defined career path and annual performance review & feedback process.
  • Cross-functional exposure to other areas of within the organization.
  • Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members.
  • 401K strong employer match.
  • Tuition Reimbursement.
  • Employee Referral Bonuses.
  • Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays.
  • Gain experience in the cutting-edge cell therapy space.