QA Consultant III

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 Duties And Responsibilities

• Perform QC Microbiology laboratory testing including bioburden, endotoxin, and sterility 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.
• Lead investigation of OOS, discrepancies, error, and failures.
• Participate in facility qualification activities for microbiological testing and environmental monitoring.
• Perform environmental monitoring of cleanroom suites and laboratory areas as required.
• Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
• Lead method transfer and method validation activities, prepare protocols and reports.
• Subject matter expert in one or more areas of required testing.
  
  

Knowledge, Skills, And Abilities

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
• Ability to work on a computer for extended periods of time
• Bachelor’s or above in Biology, Microbiology, or Biotechnology related scientific discipline.
• Minimum of 4years working experience in an FDA-regulated biotechnology or pharmaceutical company are required with environmental monitoring experience.
• Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, biological indicators, environmental monitoring, etc.
• Familiar with the USP/EP and the cGMP/EU GMP.
• Familiar with instrument and equipment validation.
• Demonstrated leadership/team management skills and experience is a plus.
• 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.
  
  

This is the pay range that Magnit reasonably expects to pay for this position: $64.29/hour - $85.71/hour

Benefits: Medical, Dental, Vision, 401K