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: $30 to $35 an hour. 

Client Industry: Pharmaceutical

Job Mode: Hybrid – Monday and Friday remote; Tuesday, Wednesday, and Thursday onsite

Duration: 12 Months Contract (Possibility of Extension based on business needs and performance.)

Job Summary:
The Project Coordinator will provide quality assurance and project support within a regulated pharmaceutical manufacturing environment.
This position will support quality projects involving product changes, quality systems, and third party manufacturing activities.
The role requires strong project coordination skills along with practical knowledge of CAPA, investigations, deviations, change control, and quality processes.
The specialist will coordinate meetings, track project actions, analyze quality metrics, identify risks, and communicate project status to management.
The position will work closely with multiple quality functions and stakeholders to ensure project activities and quality deliverables remain on schedule.

Key Responsibilities:

• Attend project and quality meetings and provide coverage when needed.
• Track meeting action items, tasks, owners, deadlines, and follow up activities.
• Support CAPA, investigation, deviation, and change control activities.
• Analyze and maintain data related to cycle times, touch times, workloads, and quality process activities.
• Support development, improvement, and maintenance of quality planning and scheduling processes.
• Analyze and report planned and unplanned quality activities and key process metrics.
• Identify potential project and quality risks and support risk assessments and mitigation strategies.
• Support development of project charters, requirements, objectives, deliverables, and success criteria.
• Coordinate project activities across multiple quality areas and stakeholders.
• Support quality activities associated with third party manufacturing operations.
• Provide project status updates and communicate relevant quality information to management.
• Support compliance and performance improvement initiatives.
• Participate in onsite activities and occasional travel to third party manufacturing locations when required.

Required Qualifications:

• Bachelor degree in a relevant field.
• Approximately 3 to 5 years of experience in quality assurance or a regulated quality environment.
• Hands on experience with CAPA, investigations, deviations, and change control.
• Experience with quality systems and regulated manufacturing processes.
• Experience with project coordination, action tracking, or project support.
• Strong organizational, analytical, written, and verbal communication skills.
• Ability to work onsite Tuesday through Thursday in Lake County, Illinois and support occasional business travel.

Preferred Qualifications:

• Experience in pharmaceutical manufacturing.
• Experience with combination products or medical devices.
• Experience supporting third party manufacturing relationships.
• Experience with quality metrics, planning, scheduling, and process improvement.
• Experience with quality management systems such as TrackWise or similar platforms.
• Experience supporting regulatory inspections or new product introduction activities.

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)