Quality Associate

Biocytogen•Waltham, MA

About The Position

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.

Requirements

Bachelor’s or Master’s degree in Biology, Bioengineering, Life Sciences, or a related field.
0-2 years of experience in a laboratory, quality, or clinical setting
Basic understanding of Quality Systems (Deviations, CAPAs, Audits)
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.
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.
Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional scientific teams.

Nice To Haves

Industry internships or academic lab management experience are highly welcomed.
Familiar with GxP concepts is a plus.

Responsibilities

Assist in the administration of the Document Control system, including the formatting, routing, and version control of policies and SOPs.
Manage the physical and digital QA archives. Ensure secure storage, accurate indexing, and controlled retrieval of raw data, completed study files, and logbooks.
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.
Periodically compile basic quality metrics (e.g., CAPA closure rates) to assist QA management in trend analysis.
Support the preparation and hosting of external client audits (document retrieval, facility readiness) and participate in routine internal audits.
Maintain the Approved Vendor List (AVL), track vendor qualification statuses, and assist in renewing quality agreements.
Assist in completing client quality questionnaires and ensuring sponsor expectations are met.
Track laboratory equipment calibration/PM schedules and maintain personnel training matrices, ensuring scientists are up-to-date on required SOPs.
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.