Laboratory Investigation Specialist

3 days ago


Marion, North Carolina, United States Computer Task Group, Inc Full time
Job Description

We are seeking a skilled Laboratory Investigation Specialist to join our team at Computer Task Group, Inc. in Marion, NC.

The successful candidate will have a strong background in quality operations and microbiology laboratory procedures, with experience conducting root cause investigations in the pharmaceutical/medical products industry.

Salary: $90,000 - $110,000 per year, depending on experience.

Key Responsibilities:

  • Determine scope, product impact, root cause, and corrective/preventive actions for microbial excursions.
  • Expedite identification of potential root causes and implement immediate mitigation actions.
  • Assemble cross-functional teams and conduct interviews to complete investigations.
  • Lead process improvement CAPA projects to ensure timely and effective closure of investigations.
  • Foster collaborative relationships to focus on high-quality investigations and effective corrective actions.
  • Manage and close investigations in compliance with business and regulatory requirements.
  • Work with Subject Matter Experts and Quality Approvers to implement CAPAs.
  • Maintain investigation and CAPA documentation in TrackWise, ensuring compliance with established practices.
  • Present and defend investigations during regulatory inspections, as required.

Requirements:

  • 2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry.
  • Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality roles.
  • Must have knowledge of FDA quality systems regulations.
  • Must have working knowledge of TrackWise system.
  • Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices.

Education:

  • Bachelor's or Master's degree in Microbiology or a related field.


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