QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
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Job Description
Project Specialistwill be required to lead, support, and/or manage selected manufacturing projects, which may include process/equipment optimization, business continuity, supplier changes, cost reduction, and sustainability initiatives, among others.
Duties & Responsabilities:
Identify, lead, support and manage manufacturing improvement projects until completion, which can include and is not limited to create multi-functional teams and require vendor or supplier process improvement.
Responsibilities include project management, planning, team facilitation and project status updates.
Responsible for the development and execution of Validation Protocols and Engineering Studies
Be able to work with cross functions teams (Manufacturing, Quality, R&D, Supply Chain, among others) to ensure project completion.
Perform NCMR’s, CAPA investigations and Validations process as required.
Promote a safe work environment. May provide recommendations on maintain the safety of the work environment.
Notify the supervisor of all observed hazardous conditions or unsafe work practices.
Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
Keeps abreast of the basic requirements for compliance in all plant areas of work and complies with those requirements.
Participate as required in training on regulatory issues affecting the facilities areas or any plant area. Brings regulatory compliance questions/issues to the attention of management.
Performs other related duties and assignments as requested.
Qualifications
Bachelor Degree in Engineering.
Project Management, Manufacturing, Validations, Lean and/or Six Sigma methodology with a valid training from an industry known trainer.
Excellent presentation and project management skills; Quality and detail oriented
Proficiency in the use of personal computer, scanner and office related equipment.
Knowledge of MS Office (Word, Excel & Power Point), MS Project, and database; proficiency in MS Excel.
Ability to perform project status presentations.
Ability to communicate in English/Spanish (Written and Spoken)
Additional Information
All your information will be kept confidential according to EEO guidelines.
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