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Specialist, Quality Control

The Steely Group

Hybrid, Holly Springs, NC

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JOB DETAILS
SKILLS
Acceptance Testing, Business Development, Code of Federal Regulations, Current Good Manufacturing Practice (cGMP), Data Migration, Documentation, High School Diploma, Laboratory Notebook, Laboratory Testing, Operational Audit, Operations Planning, Procedure Development, Process Engineering, Project/Program Management, Quality Control, Recreation, Software Configuration Management, Software Design, Standard Operating Procedures (SOP), Status Reports, Team Player, Test Data, Training/Teaching
LOCATION
Hybrid, Holly Springs, NC
POSTED
30+ days ago
This position will, under supervision, execute deliverables for a project to implement the clients new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.

This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).

This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.

This position will work in a team environment, collaborating with various colleagues in the client's network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.

Day to Day Responsibilities:
  • Participate in process engineering activities
  • Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
  • Participate in system requirement, software configuration, and design activities
  • Receive and/or verify master data for the site(s)
  • Coordinate ELN Template development and review with site SMEs
  • Support the development and review of Operational Qualifications
  • Execute User Acceptance Testing & Data Migration Verification
  • Review and provide input on training materials
  • Support training material development by providing inputs and reviews
  • Support site Instrument Qualification activities such as planning and execution
Basic Qualifications    
  • Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
  • Implementation of ELN systems in a laboratory environment.
    Knowledge of compliance requirements for system validation, good documentation practices, and laboratory requirements.
  • Ability to author control documents such as SOPs, Work Instructions, training materials, and process flow charts.

About the Company

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The Steely Group