Title: Analytical Project Manager
Shift:  MON-FRI 8:30AM - 5PM  (Onsite) 
Duration: 1 year 
Location:  Greendale IN 47025
Pay rate $60/hr  

Education: 
• Bachelor’s degree in Chemistry, Life Sciences, or a related field (Master’s a plus).

Requirements: 
• Minimum 5 years of experience in related quality and analytical sciences environment.
• Formal project management experience is a must.
• Proven experience with method qualification, transfer, contract lab oversight, and GxP regulations.
• Strong project management skills with the ability to manage complex, cross-functional initiatives.
• Excellent communication, problem-solving, and organizational skills.
• PMP certification or formal project management training is a plus.

Responsibilities: 
Project Manager:
o Lead transfer project to manage all aspects of the outside laboratory vendor transition.
o Develop and execute detailed project plans, timelines, and risk mitigation strategies.
o Coordinate the full transition with both internal stakeholders and external partners.
• Vendor Management:
o Serve as the main point of contact between Catalent and both the outgoing and incoming contract analytical organizations.
o Oversee knowledge and method transfer to ensure testing continuity and data integrity.
o Work directly with customers to ensure required approvals are managed through approved change management procedures and progressed with urgency.
• Analytical & Quality Oversight:
o Manage transfer of validated analytical methods.
o Coordinate samples being sent in parallel to both vendors during the qualification period.
o Ensure all analytical documentation is reviewed and transferred in compliance with regulatory and customer standards.
o Review and approve protocols/reports, material specifications and initiate required change controls related to the transfer.
• Regulatory Compliance:
o Ensure that all activities comply with regulatory requirements.
o Support audit readiness at the new vendor site through follow up of open corrective action plans initiated from corporate qualification inspections.
• Reporting & Communication:
o Provide regular updates to senior leadership on project status, risks, and milestones.
o Maintain clear documentation and project history in alignment with quality management systems.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.