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Investigations Consultant - 1592957

Investigations Consultant - 1592957

ProQuality Network

Customer: BMS, Manati 

Project: SCP Oversight

Position Type: Full-Time by contract with ProQuality Network

PO Number: 82297146

Reporting Requirements: The Contractor shall provide progress updates in writing amin activities performed on a weekly basis to ProQN. Contractor shall report all daily hours worked with activities, on the weekly report forms to be provided by ProQN and shall submit forms to ProQN on a timely basis on Monday’s before 5 PM. Any deviations observed will be properly documented, evaluated, and resolved to avoid any delays in the delivery of the project.

Services: The Contractor will support the oversight workstream as reviewer of investigations. 

Key Responsibilities:

  1. Investigation Review:
  • Thoroughly review and assess deviations, discrepancies, and incidents related to manufacturing processes.
  • Ensure that investigations are conducted in compliance with regulatory standards and company policies.

  1. Root Cause Analysis:
  • Collaborate with cross-functional teams to identify root causes of deviations and discrepancies.
  • Assist in developing effective corrective and preventive actions (CAPAs) to prevent recurrence.

  1. Documentation and Reporting:
  • Maintain meticulous records of investigation reviews, findings, and outcomes.
  • Prepare comprehensive reports summarizing investigation results and recommendations.

  1. Quality Assurance:
  • Ensure that manufacturing processes are executed in accordance with Good Manufacturing Practices (GMP).
  • Support quality control activities to safeguard product quality and patient safety.

  1. Continuous Improvement:
  • Contribute to ongoing process improvements by identifying areas for enhanced efficiency and compliance.
  • Participate in quality-related projects and initiatives.

  1. Training and Development:
  • Stay up-to-date with industry regulations and best practices related to deviation management and quality assurance.
  • Provide training and guidance to manufacturing personnel on investigation and CAPA processes.


  • Bachelor's degree in a scientific or engineering discipline, such as Chemistry, Biology, Pharmacy, or related field.
  • Previous experience in quality assurance, deviation management, or pharmaceutical manufacturing is highly desirable.
  • Strong analytical skills with the ability to critically evaluate complex data.
  • Excellent communication and interpersonal skills.
  • Knowledge of regulatory requirements, including FDA and international regulatory agencies.
  • Detail-oriented and committed to maintaining the highest standards of quality and compliance.
  • Ability to work collaboratively in a cross-functional team environment.

Thank you. We will be in contact soon.

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