Change Control Analyst

Kelly Science and Clinical FSP is currently seeking a Change Control Analyst for a long-term engagement in West Point, PA with one of our Global Pharmaceutical clients. This position is hybrid. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Change Control Specialist
Global Quality Large Molecule Analytical Sciences (GQLMAS) Quality Assurance QMS, within Global Quality/Manufacturing Division (MMD), is responsible for the analytical commercialization of large molecules (vaccines, biologics) and to provide in-line analytical support to enable world-wide robust vaccine and biologics supply. This team is highly motivated, fast-paced and focused on the rapid advancement of large molecule pipeline and reliable compliant supply of existing products.
Global Quality Large Molecule Analytical Sciences (GQLMAS) is seeking a motivated candidate to provide functional support for analytical change control activities for in-line products within biologics and vaccines. The candidate with a preferred scientific background will focus on analytical changes supporting in-line product analytical changes (e.g., method validations, specifications, method transfers, method improvement) with the opportunity to provide technical and laboratory support when needed.
Primary Responsibilities:

• Manage analytical change control activities associated with in-line products and ensure change control compliance with all regulatory expectations and global procedures.
• Partnering with key stakeholders in Regulatory, Analytical, Technology, Supply Chain, Operations, and Quality to coordinate assessments and approval of analytical change controls.
• Develop change strategy through creation of change plan and tasks and maintain end-to-end oversight to drive progress and escalate where required.
• Train and mentor new members of the team.

Required Experience and Skills:

• Experience and understanding of change control environment and systems
• Work independently and within cross-functional teams.
• Effective organization to multi-task and manage multiple projects
• Strong collaborative and communication skills
• Effective written and oral communication skills

Education:
BS degree required, concentrations in life sciences, engineering or related relevant discipline with 1+ yrs of relevant industry experience.