Job description

Supplier Change Control ::100% remote
Can be 100% remote but by a northeast (Kenilworth, Rahway, West Point) location
06+ Months
Qualifications: Minimum 3 yrs 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

Responsibilities: This role is for a manufacturing technical expert (min 3 yrs) 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 teammates 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 Merck'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.

Comments/Special Instructions: Can be 100% remote but by a northeast (Kenilworth, Rahway, West Point) location Experience effectively working with external suppliers. Experience with systems like SAP, IPI etc. are nice to have skillsets. Skillsets- Change control experience, tech experience, PM skillsets, technical writing.

Job Type: Contract

Pay: $25.00 - $38.00 per hour

Schedule:

• 8 hour shift

Experience:

• Quality audits: 1 year (Preferred)
• AS9100: 1 year (Preferred)
• FDA regulations: 1 year (Preferred)

License/Certification:

• Six Sigma Certification (Preferred)

Work Location: Remote

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