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System One Services Quality Control Representative in Indianapolis, Indiana

Quality Control RepresentativeIndianapolis, IN

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Type:Contract

Category:Scientific & Clinical

Job ID:156708

Date Posted:10/16/2020

Title:Quality Control Representative

Location:Indianapolis, IN

Start date:ASAP

Responsibilities:

  • Manage document formatting, revisions, routing and management through approval of docs

  • Create documents (change controls, logbooks, qualification documents)

  • Person that gets actions assigned (e.g. manage external vendors scheduling, work with IT to get data ports, execute CC tasks, etc.)

  • Maintain the validation (routine maintenance) / annual review task execution & summarize Secondary Standards management & delivery

  • Provide assistance and mentorship in investigations, change proposals, procedure and manufacturing instruction revisions and validations.

  • Assist with periodic self-inspections of the manufacturing area to assure GMP compliance and preparation for inspections by various regulatory agencies.

  • Provide leadership in establishing and maintaining Quality Systems.

  • Ensure appropriate execution of the Quality Systems to sustain a state of GMP compliance.

  • Investigates customer complaints that are associated with the quality of company products.

  • Apply cGMP principles in all phases of product complaint investigations.

  • Evaluate completed complaint investigations for accuracy and completeness prior to closure.

  • Interpret and apply regulations, policies, and guidelines.

  • Provide leadership for inspection readiness activities.

  • Ensure that the site is in a constant state of inspection readiness.

Requirements:

  • Undergraduate/Bachelors Degree or Equivalent Work Experience

  • Would need personnel with lab background and technical writing skills

  • Experience with CMMS (GMARS), vendor management, qualification protocol development and execution and technical writing skills.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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