As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!
location: Telecommute
job type: Contract
salary: $20.00 - 23.59 per hour
work hours: 9 to 5
education: High School
responsibilities:
- This position will, under SME 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.
- 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:
- GED/HS + 2 years work experience OR Associate's + 6 months work experience OR Bachelor's
- GxP experience (biopharmaceutical testing)
- GMP software development/validation testing
- Electronic Lab Notebook (ELN) systems (Biovia, ThermoFisher, LabWare, Benchling)
- Veeva & Empower experience
- Analytical methods testing/processes
- Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)
skills: GLP (Good Laboratory Practice), GCP (Good Clinical Practice), 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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
