Quality Assurance Analyst II - Sunrise Systems Inc
Fort Worth, TX 76134
About the Job
Job Title: Quality Assurance Analyst II
Location: Fort Worth, TX
Duration: 06 months on W2 Contract.
Job Description:
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.
Key Responsibilities:
Location: Fort Worth, TX
Duration: 06 months on W2 Contract.
Job Description:
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.
Key Responsibilities:
- 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.
Minimum requirements:
- 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.
- Sefl-driven, project oriented and troubleshooting are highly preferred.
Contact:
Durga Prasad: Durgaprasad.B@sunrisesys.com | 732 313 0251 | URL: www.sunrisesys.com
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Source : Sunrise Systems Inc