Help bring life-changing cell therapies from clinical trials to commercialization. As a QA Validation Contractor, you will champion compliance and data integrity across equipment, computerized systems, and facility operations in a fast-paced cGMP environment. Partner across Manufacturing, QC, Cytogenomics, and Materials Management to ensure strict FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 alignment, delivering high-quality standards and direct value to patients.
location: Westborough, Massachusetts
job type: Contract
salary: $45.00 - 56.29 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Author, execute, and review validation protocols (IOPQ), URS, RASC, FS, CS, Traceability Matrices, and risk assessments.
- Validate equipment, computerized systems, and lab instrumentation, including controlled temperature units.
- Lead data integrity initiatives, periodic reviews, and vendor qualification package evaluations.
- Partner with IT, Facilities Engineering, Manufacturing, QC, and Lab teams on deviations, root cause analyses, and CAPAs.
qualifications:
Required
- Experience supporting biologics, cell therapy and/or gene therapy in a GxP environment.
- Demonstrated knowledge of GAMP 5 principles and 21CFRpart11/EU Annex 11 regulations.
- Experience with creating and reviewing validation lifecycle documentation for laboratory benchtop instruments with computerized systems.
- Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
- Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
- Solid technical writing skills with ability to document work in a meticulous and accurate manner.
- Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.
- BS/BA in Life Sciences, Engineering, or Chemistry with 1-3+ years of GMP validation experience (or 5+ years of relevant biotech/pharma industry experience).
- Experience with an electronic document management system.
- Experience with data acquisition software, such as KAYE Validator and Ellab ValSuite dataloggers used to perform mapping studies.
skills: Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Assurance (QA)
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.
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.
