Quality Assurance Investigations Analyst

2 weeks ago


Lansdale, Pennsylvania, United States eTeam Full time

Position: Quality Assurance Investigations Analyst

Qualifications:



•Bachelor's or Master's degree in a relevant engineering or scientific discipline


•A minimum of 0-3 years of experience in a cGMP setting (such as Production, Development, Process Engineering, or Technical Services) within the pharmaceutical or biotechnology sectors


•Experience in documenting investigations for unusual occurrences in a production context


•Knowledge of Lean Six Sigma methodologies along with strong analytical and problem-solving skills


•Proven ability to work autonomously as well as collaboratively within a cross-functional team


•Strong written and verbal communication abilities

Key Responsibilities:


•The primary role involves providing daily technical assistance to manufacturing operations, focusing on the resolution and minimization of process deviations, formulating and executing corrective and preventive actions, and leading investigations in both manufacturing and laboratory settings


•This role will entail offering scientific support for manufacturing sectors within eTeam's Manufacturing Division


•The individual will cultivate collaborative relationships with peers in other departments that support aseptic manufacturing, testing, planning, and product release, employing sound scientific and engineering principles to investigate process deviations


•Troubleshooting and conducting root cause analyses of laboratory test failures and atypical manufacturing events, along with the development of corrective and preventive measures, will be essential


•The role requires analysis of complex issues through critical thinking and the design and execution of laboratory or pilot-scale experiments


•Availability for off-shift work may be necessary



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