Quality Analyst (LIMSQA)

Danvers, IL - USA

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Analyst
Location: Danvers MA
Duration : 12 Months

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 J&J 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
Bachelors 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

Job Title: Quality Analyst Location: Danvers MA Duration : 12 Months 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. ...