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)