Supplier Change Control - I

Kenilworth, NJ

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Type: Contract

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 290307

Date Posted: 09/23/2022

Start Date: 10/17/2022

End Date: 04/17/2023

Shortcut: http://jobs.systemoneservices.com/mNwNvz


Title: Supplier Change Control – I

Location: Kenilworth, NJ

Start date: ASAP

Responsibilities:

  • This role is for a manufacturing technical expert (min 3 years) with strong project management capabilities.
  • The primary function is to lead global/multi-site Change Control activities that result from Supplier changes and/or help move changes through the system.
  • The individual will interface with team mates and others in the organization to complete a variety of complicated tasks.
  • The candidate will be trained on required processes and SOP, as the process follows a standard work approach. They will also use multiple IT systems to conduct day to day work IPI, TrackWise, Tracelink, SAP, QSAT, Supplier Transparency are some examples.
  • This person would be part of a core team that is already performing this work routinely. Primary function is to execute Supplier or External Manufacturer related Change Control.
  • The candidate may also be responsible for coordinating and in some cases performing, the technical assessment of the raw material or component change as it relates to the company's drug product, depending on their skill sets.
  • The individual will enter data into a IPI Change Control system in accordance with established procedures and will help the Change Control team move changes through system.
  • Will interface with teammates and others in the organization to complete a variety of complicated tasks.
  • Additional duties will be performed as directed based on team requirements.
  • A wide degree of latitude is expected, and the individual must be able to work independently or as part of a team.

 

Requirements:

  • Minimum 3 years tech experience
  • BS in Science, Pharmacy and or Engineering; a science background is preferred, non-science degree will be consider only if they meet other qualifications.
  • Change Control Experience (Trackwise/IPI preferred).
  • Able to work in teams and influence others without a reporting relationship.
  • Solid Project management skills; organized, able to work against time lines; able to effectively manage and drive multiple projects at once. Pharmaceutical Industry, GMP, project management
  • Experience working directly with Suppliers.
  •  Raw material and/or package component technical knowledge.
  • Non-sterile product manufacturing knowledge (technical services and or development background).
  • Technical Writing
  • Experience effectively working with external suppliers.
  • Experience with systems like SAP, IPI etc. are nice to have skillsets.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, 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 full-time 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.


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