QC Analyst I, Environmental Monitoring

Job Summary

Cellipont Bioservices is growing and seeks a QC Analyst I, Environmental Monitoring who shares our passion for bridging client discoveries to patient cures and is ready to challenge the status quo.

About the role

The QC Analyst I, Environmental Monitoring supports the quality control department in a CMDO for manufacturing of cell therapy drug substance, sterile finished drug product, and fill/finish. They perform routine Environmental Monitoring, assist with EMPQ, and support aseptic process simulations and fill/finish monitoring. This role requires flexibility and cross-functional collaboration.

Responsibilities

• Perform and assist with Environmental Monitoring of Grades A-D Cleanroom environments, including viable surface sampling, viable air, and non-viable particulates.
• Assist with Growth Promotion, Sterility, Endotoxin, and Mycoplasma testing.
• Support Aseptic Process Simulations (media fills) and fill/finish monitoring, including air quality, personnel aseptic technique, and environment integrity.
• Participate in Gown Qualifications.
• Communicate results of work through discussions and documentation, with some input from supervisor.
• Flexibly follow unique campaign requirements, including off-hour and weekend work.
• Assist in inventory management and cost-effectiveness for the department.
• Be prepared 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.
• Experience working in cGMP Quality Control is a plus.
• Experience with Microsoft Office.
• Knowledge and ability to apply basic scientific and regulatory principles.

Qualifications

• Ability to work in a fast-paced environment.
• Strong ability to work cross-functionally.
• Flexibility in following unique campaign requirements.

Skills

• Basic scientific and regulatory principles.
• Environmental Monitoring and microbiological testing.
• Aseptic process simulations and fill/finish monitoring.
• Inventory management and cost-effectiveness.
• Cross-functional exposure.

Benefits

• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas of the organization.
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members.
• 401K with strong employer match.
• Tuition Reimbursement.
• Employee Referral Bonuses.
• Flexible work schedules and PTO based on role/level.