- This position will, under [SME or management 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: Newbury Park, California
job type: Contract
salary: $30.00 - 35.41 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:
Required:
- High school/GED + 2 years work experience OR Associate's + 6 months work experience OR Bachelor's.
- GxP experience (biopharma testing practices/requirements).
- Experience in development/validation testing of GMP software.
- Experience with electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
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 HRsupport@randstadusa.com.
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
