Support QA and facility compliance in a non-GLP research lab: manage document control and archives, track deviations/CAPAs/change controls, assist audits and vendor qualification, compile basic quality metrics, track equipment calibration and training matrices, monitor sample chain-of-custody, and support EHS walk-throughs.
We are seeking a detail-oriented and motivated Quality Associate to join our team. In this role, you will support the day-to-day operations of our Quality Assurance (QA) and facility compliance programs within a non-GLP, research-focused environment. You will work closely with the QA team and scientific staff to ensure scientific rigor, data integrity, and high-quality deliverables for our clients.
Key Responsibilities:- 1. Document Control & Data Governance
- 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.
- 2. Quality Management Systems
- 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.
- 3. Compliance, Audit & Vendor Support
- 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.
- 4. Operations & Facility Oversight
- Equipment & Training: Track laboratory equipment calibration/PM schedules and maintain personnel training matrices, ensuring scientists are up-to-date on required SOPs.
- Sample Management & EHS: Monitor the receipt, storage, and dispensation of Test Articles (TA) to ensure chain of custody. Support routine EHS walk-throughs to maintain a safe laboratory environment.
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
- 401K with Company Match
- Paid Time Off
- Paid Sick Days & Holidays
BIOCYTOGEN is an Equal Opportunity Employer. Employment opportunities at BIOCYTOGEN BOSTON CORP are based upon one’s qualifications and capabilities to perform the essential functions of a particular job. All employment opportunities are provided without regard to race, color religion, sex, national origin, ancestry, age, sexual orientation, gender identity and expression, veteran status, military status, disability, mental illness, genetic information, or any other characteristic protected by law. This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.
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