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QA Engineer

4 weeks ago

Lebanon, Indiana, United States Tech Tammina Full time
Job Title: QA Engineer
Location: Lebanon, IN

Job Description:

Qualifications
  • BS in Engineering or science-related field.
  • GMP manufacturing knowledge and/or experience.
  • 2+ years manufacturing experience.
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Demonstrated coaching and mentoring skills.
  • Experience in root cause analysis.
  • Demonstrated application of statistical skills.
  • Experience in API or finished product manufacturing, QA or Engineering.
  • Experience with system and equipment qualifications.
  • Knowledge of cGMPs and quality systems.
  • Demonstrated strong written and verbal communications skills.
  • Strong attention to detail.
  • Excellent interpersonal skills and networking skills.
  • Ability to organize and prioritize multiple tasks.
  • Demonstrated flexibility when faced with changing priorities.
  • Proficiency with computer system applications and process automation systems.
Responsibilities
  • The Engineer - QA is responsible for providing technical guidance and leadership to the LP1 site regarding the quality standards employed to maintain and improve site operations
  • The area of focus includes utilities, bulk distributed materials (BDMs), and facilities/equipment qualification
  • Provide direct quality oversight of production, engineering, automation, and laboratory operations
  • Review and approve documents including, but not limited to, procedures, change control proposals, deviations, and equipment/system qualification/validation
  • Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems
  • Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems
  • Conduct gap assessments of global requirements and ensure implementation of the governing standards
  • Participate in and/or lead, support self-inspection activities and regulatory inspections
  • Maintain and improve FUME quality systems
  • Assist business partners in the interpretation of regulatory and corporate requirements