What are the responsibilities and job description for the Quality Systems Analyst position at Cynet Systems?
We are looking for Quality Systems Analyst for our client in Boston, MA.
Job Title: Quality Systems Analyst
Job Location: Boston, MA
Job Type: Contract
Job Overview:
Pay Range: $120/hr - $125/hr
Requirement/Must Have:
- Bachelor s degree (scientific discipline preferred) and 4 years of demonstrated quality experience in a GMP environment or the pharmaceutical/
biopharmaceutical industry. - Strong written and verbal skills.
- Ability to communicate across various cross-functional teams.
- Ability to work independently and drive pending actions to completion.
- Experience in GXP document review.
- Strong computer skills Word, Excel, and other electronic Quality systems.
Responsibilities:
- Assist in Quality oversight for external GMP production and testing activities for clinical stage products and materials.
- Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Perform review of Regulatory submissions and source data verification.
- Assist in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations.
- Other duties as assigned.
- Manage review and approval of analytical testing protocols, methods, and qualification/validation reports.
- Support review of regulatory filing activities as needed.
- Support SMEs in managing documents through the review, approval, and release workflow in the eQMS (e.g., Veeva Vault).
- Serve as a resource and coach for SMEs navigating quality processes and eQMS workflows.
- Identify and escalate quality issues or systemic trends to Quality Management.
- Support audit readiness by ensuring quality records are complete, accurate, and on time.
- Contribute to continuous improvement initiatives within the Quality Systems function.
Salary : $120 - $125