Analytical Project Manager
Greendale, IN 47025 US | Work from home flexibility TELECOMMUTE
Job Description
SRG4 offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Location: Greendale, Indiana
- Industry: Pharmaceutical
- Hours: Monday-Friday, 8am-5pm (on-site, with some hybrid options)
- Salary: Up to $60/hr.
- Employment Type: Up to one year contract
Client Overview:
Our client is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. They develop, manufacture and package pharmaceutical and other products for customers in nearly 100 countries. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products.
Position Overview:
The Analytical Project Manager will lead the initiation of the end-to-end transfer of outsourced analytical and microbial testing services from an existing contract testing lab to a new vendor. This detail-oriented, critical role ensures continuity of analytical and technical services, compliance with regulatory standards, and seamless integration of the new vendor into our quality systems and processes.
Specific Tasks, Duties and Responsibilities:
- Lead transfer project to manage all aspects of the outside laboratory vendor transition.
- Develop and execute detailed project plans, timelines, and risk mitigation strategies.
- Coordinate the full transition with both internal stakeholders and external partners.
- Serve as the main point of contact between our company and both the outgoing and incoming contract analytical organizations.
- Oversee knowledge and method transfer to ensure testing continuity and data integrity.
- Work directly with customers to ensure required approvals are managed through approved change management procedures and progressed with urgency.
- Manage transfer of validated analytical methods.
- Coordinate samples being sent in parallel to both vendors during the qualification period.
- Ensure all analytical documentation is reviewed and transferred in compliance with regulatory and customer standards.
- Review and approve protocols/reports, material specifications and initiate required change controls related to the transfer.
- Ensure that all activities comply with regulatory requirements.
- Support audit readiness at the new vendor site through follow up of open corrective action plans initiated from corporate qualification inspections.
- Provide regular updates to senior leadership on project status, risks, and milestones.
- Maintain clear documentation and project history in alignment with quality management systems.
- Bachelor s degree in Chemistry, Life Sciences, or a related field (Master s a plus).
- 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.