Quality Analyst - LIMS

Job Title: Quality Analyst 
Location:  Raynham, MA
Duration : 12 Months
Not open C2C only W2 - Onsite role.

Job Summary

This role supports the Quality Assurance organization by maintaining and improving quality systems and product performance through effective use of LIMS (Labware/LabVantage), inspection plans, and compliance processes. The position ensures inspection data integrity, supports regulatory compliance, and drives continuous improvement across product lifecycle, manufacturing, and quality operations.

Key Responsibilities

• Quality Systems & LIMS
• Administer and support Labware v7 and LabVantage v8.8 LIMS platforms, including master data setup and inspection plan migration.
• Provide day-to-day LIMS user support, troubleshooting, reporting, and training.
• Support LIMS change control and system improvements in collaboration with IT and Quality.

Compliance & Audits

• Ensure compliance with QSR, ISO 13485, GMP, and Client standards.
• Support internal/external audits and conduct line/area audits for production controls and CAPA effectiveness.

Product Quality & NCMR

• Support Material Review Board (MRB) activities and non-conformance investigations.
• Drive defect classification, material segregation, and quality metrics tracking.

Process & Product Validation

• Draft, execute, and support IQ/OQ/PQ, TMV, and software validation activities.
• Support design transfer and new product introductions through risk management and inspection planning.

 Data & Continuous Improvement

• Perform data analysis, sampling plans, MSA, and statistical evaluations to support process improvements.
• Partner with Supply Chain, Manufacturing, and Suppliers on process controls and risk mitigation.

Qualifications Snapshot

• Bachelor’s Degree (0–2 years’ experience)
• LIMS: Labware v7 & LabVantage v8.8 (basic–intermediate)
• Strong Excel / data analysis skills
• Knowledge of GD&T, inspection methods, GMP/ISO/QSR
• Hands-on, analytical, and problem-solving mindset.

All your information will be kept confidential according to EEO guidelines.