QC Lead Analyst, Microbiology

Cellipont Bioservices • The Woodlands, TX

22h

About The Position

Cellipont Bioservices is growing, and we are looking for a QC Lead Analyst, Microbiology, who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The QC Lead Analyst, Microbiology is responsible for Environmental Monitoring sampling, analyzing, and reporting results, and microbiological testing to support manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish. The QC Lead Analyst, Microbiology applies microbiological principles to evaluate contamination risk in aseptic manufacturing, provides scientific input to cross-functional teams, and ensures laboratory testing is executed accurately, on time and in compliance with cGMP. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

Requirements

• Bachelor's degree (B.S.) in Biology, Microbiology, Biotechnology or a closely related biological science is required, with 4–5 years of relevant industry experience
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Knowledge and ability to apply biological, microbiological and regulatory principles to solve scientific and quality problems
• 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 trouble shooting skills
• Concentration of aseptic technique and contamination control
• Streak plating and microbial identification
• Document writing, data interpretation, presentation, statistical analysis and trending a plus
• Minimum supervision required on day-to-day activities and accomplished tasks
• Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor
• Experience working in cGMP Quality Control Laboratory
• Experience with Microsoft Office
• Strong attention to detail
• Familiarity with Good Manufacturing Practices (cGMP's)
• Excellent oral and written communication skills.
• Must be available to work occasional weekend or holiday support as needed

Nice To Haves

• Document writing, data interpretation, presentation, statistical analysis and trending a plus

Responsibilities

• Own, execute, and finalize Environmental Monitoring Performance Qualifications of cleanrooms
• Identify objectionable microorganisms and impact to production activities
• Implement EU Annex 1 updates to the QC procedures and EM Programs/Policies.
• Cross-train into other Quality Control testing areas as required
• Compile, trend and interpret large sets of Environmental Monitoring data and prepare technical reports.
• Perform routine Environmental Monitoring of Grade A-D Cleanroom environment, including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing facility
• Provides input on SOP revisions and assist in the creation and editing of protocols, risk assessment etc.
• Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
• Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
• Perform Gown Qualifications and BSC Qualifications
• Report and evaluate environmental monitoring excursions and OOS results, applying microbiological principles to support investigations and root-cause assessment
• Report and investigate environmental monitoring excursions and OOS results
• 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
• Ability to train fellow analysts on Environmental Monitoring and other microbiological assays
• Lead and own various Environmental Monitoring and other QC projects on an as needed basis in collaboration with other departments
• Assist in inventory management and cost effectiveness for the department
• Other duties as assigned

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 and paid holidays
• Gain experience in the cutting-edge cell therapy space

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level