QC Microbiology Data Analyst

Temporary work opportunities align well with professionals seeking career flexibility and non-traditional ways of working, while being driven to deliver exceptional results in high-profile environments. Magnit Direct Source is a service offered by Magnit Global that connects top talent directly to industry-leading clients with flexible temporary assignments across a variety of impactful projects. BeOne Medicines is creating the world’s next generation cancer treatments. As a global oncology company focused on uniting against cancer, BeOne Medicines brings together passional professionals dedicated to making a difference for patients worldwide. This opportunity is part of BeOne’s Contingent Workforce Program in partnership with Magnit Global.

As a temporary contractor supporting BeOne Medicines, you will be employed by our contingent talent partner, Magnit Global, who manages BeOne’s contingent and temporary workforce. Magnit Global is a leading workforce solutions and technology company specializing in contingent workforce management. Magnit partners with organizations across industries including healthcare, pharmaceuticals, research and development, consumer electronics and more. Magnit offers a comprehensive benefits package, including medical, dental, vision, and 401(k).

Magnit is a leading, global professional services and technology company and a certified "Great Place to Work". We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more. Magnit offers benefits including medical, dental, vision, and 401(k).

Essential Functions Of The Job

• Collect and analyze data related to Environmental Monitoring (EM), WFI, PW, Clean Steam, Compressed Air, and process gases, and prepare comprehensive trend reports to facilitate informed decision-making.
• Escalate excursions and adverse trends in a timely manner to ensure immediate corrective actions can be taken and compliance maintained.
• Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases as required Perform environmental monitoring of cleanroom suites and laboratory areas as required.
• Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.
• Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
• Manage inventory of reagents and supplies for the laboratory.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in facility qualification activities for microbiological testing and environmental monitoring.
• Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
• Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Undertake any other duties as required.
  
  

Education/Experience Required

• Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• Proficiency in data analysis software such as Excel, Power BI, or other relevant data analysis tools, with demonstrated ability to analyze and present trend data effectively.
• Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
• Familiar with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Bachelor’s Degree in Microbiology, Biology or Biotechnology related to scientific discipline.
  
  

This is the pay range that Magnit reasonably expects to pay for this position: $53.57/hour - $71.43/hour

Benefits: Medical, Dental, Vision, 401K