QA & Compliance Associate — Data Integrity

Biocytogen Pharmaceuticals Co.; Waltham (MA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

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

Job summary

BIOCYTOGEN seeks a detail-oriented Quality Associate to support QA and facility compliance in a non-GLP, research-focused environment. You will collaborate with QA and scientific staff to ensure data integrity and high-quality deliverables for clients.

Responsibilities include document control, archiving, deviations/CAPAs, audit support, vendor qualification, and equipment/training tracking to maintain compliance and safety across the facility.

Qualifications

• 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 (Industry internships or academic lab management experience are highly welcomed).
• Basic understanding of Quality Systems (Deviations, CAPAs, Audits); familiar with GxP concepts is a plus.
• High digital literacy and efficiency. Proficient in Microsoft Office Suite (Word formatting, Excel data management) and quick to master new electronic tracking systems and document control software.
• A self-starter with a results-oriented approach. Ability to work independently, prioritize tasks efficiently, and deliver high‑quality work without constant micromanagement.
• Excellent written and verbal communication skills, with ability to collaborate effectively with cross‑functional scientific teams.

Responsibilities

• Assist in document control system administration: formatting, routing, version control of policies and SOPs.
• Manage physical and digital QA archives; secure storage, indexing, and retrieval of data and logs.
• Log, track, and follow up on Deviations, CAPAs, and Change Controls; ensure investigations are documented within timelines.
• Periodically compile basic quality metrics (e.g., CAPA closure rates) for trend analysis.
• Support audit readiness: document retrieval, facility readiness for client audits; participate in internal audits.
• Maintain Approved Vendor List (AVL) and assist in renewing quality agreements.
• Assist in completing client quality questionnaires and meeting sponsor expectations.
• Track laboratory equipment calibration/PM schedules and maintain training matrices.
• Monitor receipt, storage, and dispensation of Test Articles; support EHS walkthroughs to ensure lab safety.

Skills

Document control

Data governance

Microsoft Office

Quality mindset

Communication

Independent work

Education

Bachelor’s or Master’s degree in Biology/Bioengineering/Life Sciences

Tools

Document control software

Electronic tracking systems

Job description

BIOCYTOGEN seeks a detail-oriented Quality Associate to support QA and facility compliance in a non-GLP, research-focused environment. You will collaborate with QA and scientific staff to ensure data integrity and high-quality deliverables for clients.

Responsibilities include document control, archiving, deviations/CAPAs, audit support, vendor qualification, and equipment/training tracking to maintain compliance and safety across the facility.