To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $35/hr to $40/hr
Job Title: Quality Assurance QA Specialist III
Location: North Chicago, IL 60085
Work Type: Hybrid
Contract Duration: 12 months with possible extension

Job Summary:

• The Quality Assurance QA Specialist III will provide quality assurance support for pharmaceutical manufacturing operations and ensure compliance with applicable corporate and governmental quality requirements.
• This role will lead and coordinate quality projects across multiple site QA areas while supporting continuous improvement and operational excellence initiatives.
• The position will collaborate with QA planners and centralized quality functions to drive project deliverables and support the deployment of global pharmaceutical initiatives.
• The specialist will analyze quality process data, monitor performance metrics, identify operational risks, and implement appropriate mitigation strategies.
• The role will also support regulatory inspections, compliance initiatives, performance improvement projects, and effective collaboration with quality teams and third party contractors.

Key Responsibilities:

• Develop plans, coordinate activities, and drive execution of quality projects across multiple site QA areas.
• Coordinate with site QA planners to achieve project deliverables and maintain effective project schedules.
• Coordinate with centralized quality functions to support deployment of global pharmaceutical initiatives.
• Analyze, manage, and maintain data related to cycle times, touch times, tasks, and process lists to optimize QA process performance.
• Drive the development, improvement, and maintenance of site QA planning and scheduling activities.
• Ensure QA areas within project scope implement and maintain visual management tools for monitoring key quality processes.
• Analyze and report planned and unplanned activity metrics for key QA processes.
  Identify potential areas of risk and implement early risk assessments, mitigation strategies, and fallback plans.
• Lead the development of project charters and document requirements that address stakeholder needs and expectations.
• Establish project objectives and criteria for evaluating project results and team activities.
• Support regulatory inspections associated with new market introductions.
• Lead or coordinate compliance and performance improvement projects and provide project status updates to site management.
• Maintain effective communication and collaboration with quality teams from third party contractors.

Required Qualifications:

• Bachelor’s degree in a relevant scientific, engineering, quality, or related discipline.
• Experience working within pharmaceutical quality assurance or regulated manufacturing environments.
• Strong knowledge of quality systems and quality compliance practices.
• Experience with project planning, coordination, execution, and stakeholder management.
• Strong written and verbal communication skills.
• Working knowledge of aseptic processes and pharmaceutical manufacturing operations.
• Experience working with combination products or related regulated products.

Preferred Qualifications:

• Experience supporting regulatory inspections and new market introductions.
• Experience with quality performance improvement and compliance projects.
• Experience analyzing quality metrics, cycle times, and process performance data.
• Experience working with visual management tools and quality planning systems.
• Experience collaborating with third party contractors and cross functional quality teams.

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)