Quality Analyst LIMS
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Job Location:
Raynham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors Degree (02 years experience)
- LIMS: Labware v7 & LabVantage v8.8 (basicintermediate)
- Strong Excel / data analysis skills
- Knowledge of GD&T inspection methods GMP/ISO/QSR
- Hands-on analytical and problem-solving mindset.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Key Skills
- Gas Chromatography
- Laboratory Experience
- Archival Standards
- ELISA
- Test Cases
- Analytical Chemistry
- Quality Assurance
- Spectroscopy
- Quality Control
- cGMP
- Selenium
- Western Blot
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
