Senior Quality Assurance Specialist

6 days ago


Lansdale, Pennsylvania, United States eTeam Full time

Job Title: Senior Quality Assurance Specialist - Manufacturing Operations


About the Role:


eTeam is seeking a highly skilled Senior Quality Assurance Specialist - Manufacturing Operations to join our team. In this role, you will be responsible for providing day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations.


Main Responsibilities:



  • Resolution and reduction of process deviations in manufacturing operations
  • Development and implementation of corrective/preventative actions
  • Leading manufacturing and laboratory investigations
  • Providing scientific support for manufacturing areas within eTeam's Manufacturing Division (MMD)
  • Developing working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release
  • Real-time troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events
  • Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments

Required Qualifications:


eTeam requires a B.S./M.S. degree in Mechanical or Chemical Engineering or other science degree. 0-3+ years of relevant work experience in a cGMP environment is preferred. Relevant experience in vaccine operations or technical services support is also desirable.


Key Skills:



  • Experience with troubleshooting biotech equipment, barrier technology, and closed system processing
  • Familiarity with MEDS and SAP systems
  • Ability to read Piping and Instrumentation Diagrams
  • Familiarity with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities
  • Excellent written and verbal communication skills
  • Demonstrated ability to work both independently and as a part of a cross-functional team

Benefits:


eTeam offers a competitive salary of $41.78/hr based on the national average for similar positions. The location of West Point, PA contributes to the estimated annual salary range of $86,000 - $110,000. Off-shift work may be required.



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