Specialist Quality Control

Duration: 12 months Contract

Description: Note:
This position will be Hybrid. The candidate must be located near Holly Springs, NC.

• This position will, under supervision, execute deliverables for a project to implement client 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 network to ensure project commitments are met. They will report status/updates of key responsibilities and elevate any issues through the project management team.

• 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.

• 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

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US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.