Quality Assurance Specialist

1 day ago


Lebanon, Pennsylvania, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. The successful candidate will be responsible for providing technical guidance and leadership to the LP1 site regarding quality standards employed to maintain and improve site operations.

Key Responsibilities
  • Provide direct quality oversight of production, engineering, automation, and laboratory operations.
  • Review and approve documents including procedures, change control proposals, deviations, and equipment/system qualification/validation.
  • Provide coaching, feedback, and mentoring to engineering and QA teams.
  • Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
  • Conduct gap assessments of global requirements and ensure implementation of governing standards.
  • Participate in and/or lead support self-inspection activities and regulatory inspections.
Requirements
  • BS in Engineering or science-related field.
  • GMP manufacturing knowledge and/or experience.
  • 2+ years manufacturing experience.
  • Must be mobile to Puerto Rico.
Preferred Qualifications
  • 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.


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