Quality Associate
JobsInMass.com · Waltham, MA · 2 days ago
Quality AssuranceFull-time
Key Responsibilities
- Lifecycle Management: Assist in the administration of the Document Control system, including the formatting, routing, and version control of policies and SOPs
- Archiving: Manage the physical and digital QA archives. Ensure secure storage, accurate indexing, and controlled retrieval of raw data, completed study files, and logbooks
- Event Tracking: Assist in logging, tracking, and following up on Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls to ensure investigations and facility modifications are properly documented and resolved within timelines
- Metrics Reporting: Periodically compile basic quality metrics (e.g., CAPA closure rates) to assist QA management in trend analysis
- Audit Readiness: Support the preparation and hosting of external client audits (document retrieval, facility readiness) and participate in routine internal audits
- Vendor Qualification: Maintain the Approved Vendor List (AVL), track vendor qualification statuses, and assist in renewing quality agreements
- Client Inquiries: Assist in completing client quality questionnaires and ensuring sponsor expectations are met
Requirements
- Education: Bachelor's or Master's degree in Biology, Bioengineering, Life Sciences, or a related field
- Experience: 0-2 years of experience in a laboratory, quality, or clinical setting (Industry internships or academic lab management experience are highly welcomed)
- Quality Mindset: Basic understanding of Quality Systems (Deviations, CAPAs, Audits); familiar with GxP concepts is a plus
- Technical Savviness: High digital literacy and efficiency. Must be highly proficient in Microsoft Office Suite (Word formatting, Excel data management) and demonstrate the ability to quickly master new electronic tracking systems and document control software
- Work Style: A self-starter with a results-oriented approach. Must possess the ability to work independently, prioritize tasks efficiently, and deliver high-quality work without requiring constant micromanagement
- Communication: Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional scientific teams
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Reimbursement Accounts
- Life and AD&D Insurance
- Short & Long Term Disability Insurance
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