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Quality Assurance Specialist - GMP

Contract: Lake County, Illinois, US

Salary Range: 35.00 - 40.00 | Per Hour

Job Code: 367268

End Date: 2026-02-28

Days Left: 9 days, 15 hours left

To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $35 to $40 per hour.

Industry: Pharmaceutical

Contract Duration: 10 Months with possibility of extension

Job Summary:

  • This role supports global quality risk management initiatives within a regulated pharmaceutical environment.
  • The position focuses on governance execution risk assessment and regulatory aligned decision making.
  • The individual will lead cross functional projects and drive quality risk deliverables across global teams.
  • The role strengthens quality systems through practical application of global regulations.
  • Strong ownership communication and execution skills are required in a fast paced environment.

Key Responsibilities:

  • Lead and facilitate quality risk management project meetings with global stakeholders.
  • Develop and execute regulatory aligned risk assessments and governance documentation.
  • Track project milestones deliverables and timelines to ensure on time execution.
  • Perform quality review of risk management and governance documentation.
  • Collaborate with quality manufacturing supply chain and scientific teams.
  • Develop metrics dashboards and visualizations for executive level reporting.
  • Maintain records supporting quality system initiatives and compliance.
  • Support global quality system improvements and strategic transformation initiatives.

Required Qualifications:

  • Minimum 5 years of experience in quality assurance quality systems or quality risk management.
  • Hands on experience with regulatory compliance and quality risk governance.
  • Proven project management experience supporting global or cross functional initiatives.
  • Strong knowledge of GMP and global regulatory guidelines including ICH US and EU.
  • Experience performing risk assessments governance frameworks and mitigation planning.
  • Experience with document control and change management processes.
  • Working knowledge of electronic quality management systems.
  • Intermediate to advanced proficiency with Enterprise tools including Excel, PowerPoint, Visio, PowerBI, Word, Teams and SharePoint.
  • Experience developing metrics dashboards and executive reporting.
  • Ability to work independently while managing multiple priorities.
  • Bachelors degree in a scientific or technical discipline such as biology chemistry engineering or pharmacy.

Preferred Qualifications:

  • Experience developing digital or automated quality tools.
  • Previous experience working in global cross functional environments.
  • Strong PowerBI dashboard development experience.
  • Advanced executive level presentation and communication skills.

Benefits:
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

Job Requirement
  • Quality Assurance
  • Quality Risk Management
  • GMP Compliance
  • Regulatory Guidelines
  • Project Management
  • Document Control
  • Dashboard Reporting
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Deepak Arya
  • deepak.arya@collabera.com
Apply Now
Apply Now
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