Senior Quality Control Analyst, Microbiology

"Bridging innovation to cure"

Developing and manufacturing your cell therapies from benchtop to bedside.

Job Summary

Cellipont Bioservices is growing, and we are looking for a SeniorQC Analyst, Microbiology, 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 Senior QC Analyst is responsible for environmental monitoring sampling, analyzing, and reporting results, and microbiological testing to support manufacturing. This individual will work in a fast-paced environment supporting the Quality Control department for a cell therapy CDMO.

The SeniorQC Analyst 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

• Independently perform environmental monitoring of Grades B-D Cleanroom environment, Grade A BSCs, and 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.
• Conducts endotoxin testing on prepared buffers/solutions, equipment cleaning samples, and in-process, and release drug product samples.
• Perform and assist with growth promotion, sterility, and mycoplasma testing.
• Ability to isolate and sub-culture microorganisms for identification.
• Provides input on SOP revisions and may assist in the creation and editing of protocols, risk assessment, etc.
• Performs aseptic process simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
• Ability to perform gown qualifications.
• Compilation of Environmental Monitoring data for reporting purposes.
• Report on environmental monitoring excursions and OOS results.
• Effectively and promptly communicate and document test results to the required teams after a thorough review with management.
• Flexibility with schedule to support operations that may include off-hour and weekend work.
• Ability to cross-train into other streams of Quality Control.
• Other duties as assigned.

The Candidate

• B.S. in Life Sciences discipline with 2-3 years of relevant industry experience or A.S. with 3-5 years of relevant industry experience.
• Experience with BacT/ALERT, BioFire, EndoSafe or other endotoxin instrumentation is a plus.
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Experience with viable and non-viable Environment Monitoring collection instruments.
• Creative individual with outstanding troubleshooting skills.
• Builds credibility within the lab group by performing high-quality work.
• Knowledge of aseptic technique and contamination control.
• Experience in streak plating and microbial identification.
• Minimum supervision required on day-to-day activities and accomplishment of tasks.
• Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor.
• Experience working in cGMP Quality Control is required.
• Experience with Microsoft Office
• Familiarity with Good Manufacturing Practices (cGMP's)
• 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 benefits 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

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Thank you.