Quality Control Senior Associate

Job Description

job summary:

This position will, under BPO 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: West Greenwich, Rhode Island

job type: Contract

salary: $20.00 - 24.70 per hour

work hours: 9 to 5

education: Bachelors

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 diploma / GED with 2 years work experience OR Associate's + 6 months work experience OR Bachelor's degree

GxP experience (biopharma testing practices/requirements)

Experience in development/validation testing of GMP software

Experience with electronic lab notebook systems (Biovia OneLab, etc.)

Experience using industry systems like Veeva & Empower

Experience testing or with analytical methods

LI-MT-1

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 .

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.

Full-time