Operation Planner II

Kelly Science and Clinical FSP is currently seeking a Operation Planner II for a long-term engagement with one of our Global Pharmaceutical clients in West Point, PA. 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, Vison, 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.

Job Summary:

The Operations Planner II is responsible for advanced planning activities and mentoring of
junior level peers. This role requires strong business acumen and the ability to navigate
cross-functionally.  This role is responsible for independently coordinating all activities
associated with timely packaging, labeling and assembly of clinical materials for
designated domestic and international studies in accordance with applicable safety and
regulatory requirements as well as company policies. This individual is responsible for
execution of clinical supplies activities including but are not limited to the processing of
study specific packaging and labeling documentation, coordination of packaging jobs as
they progress through work-centers, and review of documentation and procedures.   

Key Responsibilities:

• Execute and lead planning activities for program level tasks and follow up on their completion.

• Operationalize documents detailing protocol level packaging and labeling strategy for internally and externally packaged clinical supplies 

• Execute and oversee planning of clinical packaging events at internal and external packaging facilities.  

• Manage Re-Packaging and R.E.D. Extension packaging jobs, including drug salvage operations

• Track deliverables at 3rd party vendors to support clinical packaging jobs
  

• Monitors the adherence to project schedules and documents progress in respective databases.

• Mentor junior level peers and provide guidance on planning processes.
  

• Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drugsupply.  

• Collaborate with cross-functional teams to support business objectives 
  

• Triage events and issues as required to ensure study timelines are met 
  

• Collaborate with Project Managers, Planners, Packaging Supervisors and Quality Assurance for the creation, review and approvals of labeling and packaging documentation.    

• Provide input, contribute to, and define process improvements
  

• Participate and lead meetings with GCS and GCS stakeholders internally and externally to Operations Planning

• Possess strong organizational, time management and analytical problem-solving skills, with ability to prioritize to mitigate supply chain risks

• Ability to use SAP system to translate clinical trial packaging and labeling designs into electronic pharmaceutical production records and preparation of executablemaster data

• Demonstrate strong working knowledge of process/systems required to ensure successful execution of Operations Planning deliverables, including but not limitedto, SAP, CSST Appian, Microsoft Office, including Excel, SWMS

• Build teamwork to improve process and productivity by working within and across client functional areas

• Complete all trainings as required
  

• Complete GMP documentation
  

• Contribute to or author SOPs, CJAs, BTDs, and Job Aids
  

• Contribute to or author investigations.
  

• Contribute to or define and manage CAPAs 
  

• Report potential quality events, non-conformance to GMPs/SOPs when observed 
  

• Contribute to or generate Change Control/Change Management records. 

Qualifications:

• Bachelor’s degree preferred; candidates with relevant experience may be considered.

• 4+ years of experience in a related field; candidates without a degree should have 7+ years of relevant experience.

• Direct work experience with SAP is a plus
  

• Above average proficiency in Microsoft applications (Word, Excel, PowerPoint)

General Skills:

• Strong forecasting and collaboration skills.
  

• Detail-oriented with strong organizational abilities.
  

• Problem-solving and project management skills.
  

• Ability to navigate cross-functionally 

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