Quality Associate

About the Role

Biocytogen is seeking a detail-oriented and motivated Quality Associate to support daily operations of Quality Assurance (QA) and facility compliance within a non-GLP, research-focused environment. This role involves close collaboration with the QA team and scientific staff to uphold scientific rigor, ensure data integrity, and deliver high-quality outcomes for clients.

Key Responsibilities

• Administer the Document Control system, managing the lifecycle of policies and SOPs, including formatting, routing, and version control.
• Oversee the physical and digital QA archives, ensuring secure storage, accurate indexing, and controlled retrieval of study files and logbooks.
• Log, track, and follow up on Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls, ensuring timely documentation and resolution.
• Compile basic quality metrics, such as CAPA closure rates, to aid QA management in trend analysis.
• Support external client audits by preparing documentation and ensuring facility readiness, and participate in internal audits.
• Maintain the Approved Vendor List (AVL), monitor vendor qualification statuses, and assist with renewing quality agreements.
• Complete client quality questionnaires and ensure sponsor expectations are met.
• Track laboratory equipment calibration and preventive maintenance schedules.
• Maintain personnel training matrices to ensure scientists are up-to-date with required SOPs.
• Monitor the receipt, storage, and dispensation of Test Articles (TA) to maintain chain of custody.
• Support routine Environmental Health and Safety (EHS) walk-throughs to ensure a safe laboratory environment.

Requirements

• Possess a Bachelor's or Master's degree in Biology, Bioengineering, Life Sciences, or a related discipline.
• Have 0-2 years of experience in a laboratory, quality assurance, or clinical setting; internships or academic lab management experience are highly valued.
• Demonstrate a foundational understanding of Quality Systems, including Deviations, CAPAs, and Audits; familiarity with GxP concepts is advantageous.
• Exhibit high digital literacy and proficiency, particularly with Microsoft Office Suite (Word formatting, Excel data management), and a capacity to rapidly learn new electronic tracking and document control systems.
• Exhibit a self-starting, results-oriented work style, with the ability to prioritize tasks effectively and produce high-quality work independently.
• Possess excellent written and verbal communication skills, enabling effective collaboration with diverse 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

Additional Information

BIOCYTOGEN is an Equal Opportunity Employer. Employment decisions are based on qualifications and capabilities, 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 policy applies to all aspects of employment, including recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, benefits, and training.