Specialist Quality Control

job summary:
This position will, under supervision, execute deliverables for a project to implement Company's 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 Company network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.

location: Holly Springs, North Carolina
job type: Contract
salary: $38.00 - 42.21 per hour
work hours: 9 to 5
education: High School

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

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

#LI-HK1

skills: Electronic Laboratory Notebook (ELN), SOP Development


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.