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Research Associate, QA Specialist - Analyst/Manager
Job in
Framingham, Middlesex County, Massachusetts, 01704, USA
Listed on 2026-08-19
Listing for:
Yoh,-A-Day-
Full Time
position Listed on 2026-08-19
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Yoh presents an excellent long‑term Research Associate opportunity with a trusted, long‑term client located in Framingham, MA
.
This position is part of a major pharmaceutical company
, and requires a
Bachelors of Science and experience working in a pharmaceutical, biotechnology, or research laboratory
. Schedule is full‑time M‑F (7am‑8am start time, 8 hour shift) and may require flexibility to work some evenings and overtime due to projects.
Laboratory Implementation Support
- Support laboratory system and technology implementation activities across sites.
- Gather, document, and clarify business and laboratory requirements through engagement with key stakeholders.
- Support implementation planning, milestone tracking, status reporting, and overall project execution.
- Coordinate activities across business, technical, laboratory, Quality, and other cross‑functional teams.
- Assist with system integration, testing, User Acceptance Testing (UAT), and go‑live readiness activities.
- Execute test scripts, document results, and collect supporting evidence in accordance with approved procedures.
- Support change management activities, issue tracking, risk identification, and implementation documentation.
- Maintain clear and accurate project records, action items, decisions, and implementation deliverables.
- Support validation and qualification planning, execution, and documentation for laboratory systems and instruments.
- Execute approved validation test scripts and accurately document test results and supporting evidence.
- Assist with the identification, documentation, and resolution of deviations, test failures, and implementation issues.
- Coordinate corrective actions, retesting activities, and follow‑up documentation through completion.
- Support the preparation, review, and completion of validation packages and associated records.
- Ensure validation activities comply with applicable procedures, quality requirements, data integrity principles, and regulatory expectations.
- Collaborate with Quality, Validation, IT, laboratory personnel, and other stakeholders to address validation‑related issues.
- Provide day‑to‑day operational support for computerized laboratory instruments, applications, and associated systems.
- Monitor system performance and support the continued availability and reliability of laboratory technologies.
- Coordinate preventive maintenance, calibration activities, software updates, and other scheduled system activities.
- Troubleshoot laboratory instrument, software, and system integration issues and coordinate resolution with appropriate technical teams.
- Work with external vendors to troubleshoot issues, schedule service activities, and manage support escalations.
- Administer support tickets and track issues, actions, and resolutions through closure.
- Develop and maintain troubleshooting guides, knowledge articles, system documentation, and other support materials.
- Assist with system lifecycle activities, including upgrades, configuration changes, testing, and implementation of system improvements.
- Escalate system issues appropriately to minimize disruption to laboratory operations.
- Bachelor’s degree in Biology, Chemistry, Biochemistry, Life Sciences, Engineering, Computer Science, or a related scientific/technical discipline.
- Experience working in a pharmaceutical, biotechnology, research, laboratory, or other regulated environment preferred.
- Experience with computerized laboratory systems, laboratory instruments, or laboratory informatics platforms preferred.
- Familiarity with system implementation, validation/qualification, testing, or UAT activities is preferred.
- Understanding of GMP/GxP principles, data integrity, validation practices, and regulated documentation requirements is preferred.
- Strong technical aptitude with the ability to troubleshoot laboratory system and instrument issues.
- Strong organizational skills and attention to detail, particularly when executing test scripts and maintaining controlled documentation.
- Effective written and verbal communication skills with the ability to collaborate across laboratory,…
Position Requirements
10+ Years
work experience
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