QC Analyst I, Environmental Monitoring

Job Summary

Cellipont Bioservices is growing, and we are looking for a QC Analyst I, Environmental Monitoring who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QC Analyst I, Environmental Monitoring is responsible for Environmental Monitoring sampling, analyzing, and reporting results, and microbiological testing to support manufacturing. Works in a fast-paced environment supporting the quality control department of a CMDO for manufacturing of cell therapy drug substance, sterile finished drug product, and fill/finish. The QC Analyst I, Environmental Monitoring is also responsible for ensuring all personnel activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate a strong ability to work cross-functionally.

The Role

• Assist in the performance of 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.
• Perform and assist with Environmental Monitoring Performance Qualifications (EMPQ) of cleanrooms.
• Perform and assist with growth promotion, sterility, endotoxin, and mycoplasma testing.
• Assists in the performance of Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
• Supports Gown Qualifications.
• Effectively communicates 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.

The Candidate

• 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
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

Position Benefits

• 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