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Lead Investigator - 1898407

Title: Lead Investigator Reviewer (Biotech Indutry)

100% Onsite Work

Location: Maryland, USA

We are seeking a highly skilled and experienced Lead Investigator Reviewer to join our team in the Biotech industry. This position requires 100% onsite presence with the flexibility for relocation to Maryland, USA.


  1. Lead and conduct investigations into deviations, non-conformances, and incidents in compliance with regulatory requirements and our client company policies.
  2. Review and approve investigation reports, ensuring thoroughness, accuracy, and adherence to established procedures.
  3. Collaborate with cross-functional teams to identify root causes, implement corrective and preventive actions (CAPAs), and drive continuous improvement initiatives.
  4. Provide guidance and training to team members on investigation processes, regulatory standards, and best practices.
  5. Maintain documentation and records related to investigations, ensuring completeness and compliance with regulatory guidelines.
  6. Participate in regulatory inspections and audits, providing support and documentation as needed.
  7. Stay updated with industry trends, regulations, and best practices related to investigation and quality management.


  1. Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry) required; advanced degree preferred.
  2. Minimum of 5 years of experience in investigations, quality assurance, or a related role in the biotech or pharmaceutical industry.
  3. Strong knowledge of cGMP, FDA regulations, and international standards (e.g., ICH guidelines).
  4. Experience with root cause analysis, CAPA management, and quality risk management.
  5. Excellent analytical, problem-solving, and decision-making skills.
  6. Ability to work collaboratively in a team environment and communicate effectively across all levels of the organization.
  7. Detail-oriented with strong organizational and time management skills.
  8. Certification in Quality Management (e.g., ASQ Certified Quality Auditor) is a plus.

If you are a dedicated professional with a passion for quality and compliance in the biotech industry, we encourage you to apply for this exciting opportunity. Join us in making a difference through excellence in investigation and quality assurance.

To apply, please send your resume to with the subject line: Lead Investigator Reviewer - Biotech Industry. We look forward to hearing from you!

Thank you. We will be in contact soon.

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