Principal Quality Assurance Engineer

Noblesville, Indiana Quality Engineering 20 days ago

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Summary: Seeking a Principal Quality Assurance Engineer with extensive experience in pharmaceutical manufacturing and quality systems oversight.

  • Requirements:

    • 8+ years of experience in Quality or Validation in pharmaceutical manufacturing
    • Bachelor of Science in Biology, Chemistry, Life Sciences, or related field
    • Knowledge of pharmaceutical quality systems including Validation, Engineering, Maintenance, Manufacturing, QC, Regulatory, CAPA, Deviations, Investigations

  • Preferred Skills:

    • Proficiency in quality oversight and regulatory compliance
    • Experience conducting on-site inspections for regulatory agencies
    • Working knowledge of cGMP guidelines

  • Responsibilities:

    • Lead development and maintenance of facility's quality systems and procedures
    • Review and approve Change Control/Process Management Documents
    • Serve as key personnel for FDA or other regulatory audits
    • Review and approve IOQs, SOPs, validation documents and data integrity assessments
    • Analyze QA system data for compliance and improvement opportunities


Pay Details: $45.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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