Quality Assurance Analyst II

job summary :

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena.

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We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

responsibilities :

• This position, using in-depth knowledge of relevant guidance / regulatory documents, is responsible for instrument qualifications and applications (LIMS, Chromeleon, etc), participate in product / process investigations as needed, ensuring required quality and safety standards are being met for our products and processes.
• Perform instrument preventive maintenance, performance verification per schedule and per standards / SOPs as needed.
• Perform instrument trouble shooting, support investigation per standards / SOPs as needed.
• Write or review validation protocols and technical reports.
• Review internal documents / external documents, make recommendation as needed.
• Collect, calculate, interpret, document and report test results per ALCOA principles.
• Write and take ownership for SOPs related to testing programs, laboratory operations and / or equipment operation, for validation projects, activities related to instrument qualification, for instrument lifecycle management include procurement, qualification, in-use, maintenance / calibration, performance review and retirement.
• Perform investigative testing to support laboratory investigations; participate in root cause analysis; lead and write laboratory investigations.

Investigate laboratory quality issues and recommend sound corrective actions and resolution.

• Perform and review equipment calibration and maintenance; serve as instrument advocate.
• Identify appropriate lab instrumentation purchases; perform qualification / validation.
• Conduct peer review and approval of data collected by coworkers.
• Lead laboratory initiatives or programs.
• Train analysts on internal procedures and test methods.
• Perform statistical analysis.
• Utilize change control systems and Inventory management.
• Act as an SME for critical processes and testing.
• Lead day to day activities acting as a backup to the supervisor as needed.
• Support tracking and reporting laboratory performance metrics.

qualifications :

• Bachelor’s Degree or Equivalent years of directly related experience or high school +16 yrs; Assoc.+10yrs; M.S & PhD.+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience
• 2 Years of Demonstrated Leadership Chemistry background with experience in analytical instrument is a must.
• Self-driven, project oriented and troubleshooting are highly preferred.

skills :

SOP, Quality Assurance, Laboratory Information Management Systems (LIMS), LIMS (Laboratory Information Management System