Quality Control Analyst III

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Job description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Summary

The Quality Control Analyst plays a vital role in the environmental monitoring of clinical manufacturing aseptic processes, sterility and lot release testing, and purified water testing while also preparing the Quality Control processes for commercial launch.

Client Details

Our client is a top privately held biotech company with an innovative technology platform focused on the treatment of retinal diseases.

Description

• Perform routine environmental monitoring of the ISO-5, ISO-7, and ISO-8 clean room suites during aseptic processing activities:
• Non-viable airborne particulate counts
• Viable airborne particulate monitoring
• Viable surface monitoring
• Personnel monitoring

• Perform growth promotion, sterility, and pH testing of all microbial growth media lots
• Perform sterility testing of drug substance and finished drug product
• Perform TOC and conductivity testing of potable and purified water samples
• Perform microbial testing (Standard Methods Agar culture and Colilert) of potable and purified water samples
• Perform endotoxin testing on finished drug product and clean steam samples; qualify new lots of CSE standard, lysate, and cartridges
• Perform Gram stain, as necessary, for preliminary identification of microbial isolates
• Follow standard operating procedures
• Good documentation skills, maintain laboratory notebooks, and attention to detail
• Schedule preventive maintenance and calibration of equipment and troubleshooting, as necessary
• Maintain reagent and laboratory supplies
• Review documents and laboratory test results; interpret and summarize results
• Initiate and revise SOPs; Perform studies according to protocols
• Generate period environment tal monitoring summary reports
• Analyze data and write summary reports, as needed

Profile

• Must have a bachelor's degree in a related science (biology, microbiology, biochemistry, etc.)
• Must have 5 - 8 years experience in a cGMP laboratory and cleanroom environment, experience in Quality Control preferred

• Must be proficient in basic laboratory and cleanroom aseptic techniques, good documentation skills, and maintain and clean and safe work environment following company safety procedures
• Experienced in performing microbiology testing procedures, TOC/conductivity, sterility, environmental monitoring of clean rooms, and basic troubleshooting
• Must havecGMP/GLP experience with the ability to interpret and apply USP methods and FDA guidance
• Candidate needs to be highly motivated and flexible, with the ability to effectively communicate and to work independently day to day and collaboratively on project team
• Strong oral and written communication skills with experience in writing SOPs and technical reports
• Must be proficient in Microsoft Office (Word, Outlook, Excel, PowerPoint)
• Must be detail oriented with good organizational and planning skills
• Must be reliable and possess a positive attitude, willingness to learn and perform hands-on daily operations

Job Offer

• Competitive base salary and benefit package
• Opportunity for career growth and development
• Join rapidly growing QC function at a clinical stage Biotech company