Quality Assurance Associate

The Quality Assurance Associate plays a key role in supporting daily QA operations within a regulated tissue banking manufacturing environment. This entry-level position is responsible for executing routine quality assurance tasks such as document review, controlled material inspections, logbook audits, and ensuring compliance with internal procedures and applicable regulatory requirements (e.g., 21 CFR 1271, AATB Standards).

This is an excellent opportunity for individuals looking to start a career in quality assurance, regulatory compliance, or biotech manufacturing. The QA Associate works closely with experienced QA staff and cross-functional departments to ensure high standards of quality and regulatory adherence are maintained throughout tissue processing operations.

Responsibilities

·     Perform routine review of batch records, logbooks, and other documentation for completeness, accuracy, and compliance.

·     Assist with line clearances, room releases, and real-time QA checks in processing and manufacturing areas.

·     Create product and process labels based on approved templates and specifications.

·     Verify accuracy of labels prior to printing and application, ensuring correct donor, lot, expiration, and regulatory information is displayed.

·     Conduct inspections of incoming materials and supplies for conformance to specifications and documentation requirements.

·     Support document control processes including routing, tracking, and archiving of SOPs, forms, and records.

·     Verify proper documentation practices (GDP) are followed throughout operations.

·     Assist in data entry, file maintenance, and preparation of quality metrics or audit materials.

·     Support deviation tracking, non-conformance documentation, and QA-related investigations as assigned.

·     Participate in internal audits, quality meetings, and training sessions.

·     Escalate observed issues, errors, or deviations to QA leadership in a timely and accurate manner.

Comply with gowning, cleanroom, and environmental control procedures as needed.

Qualifications

·     Bachelor’s degree in Life Sciences, Biology, Biotechnology, or a related field preferred.

·     Associate degree with relevant experience in a regulated industry may be considered.

·     2 years of experience in a quality, regulatory, or laboratory role in a tissue bank, pharmaceutical, medical device, or biotech environment.

·     Internship or co-op experience in a regulated manufacturing setting is a plus.

·     Basic knowledge of Good Documentation Practices (GDP) and regulatory requirements (e.g., FDA, AATB, 21 CFR 1271) is desirable.

·     Familiarity with label printing systems and verification workflows preferred.

·     Strong attention to detail, organizational skills, and willingness to learn.

·     Ability to follow written procedures and work instructions with consistency and accuracy.

·     Strong communication and teamwork skills.

·     Proficiency in Microsoft Office (Word, Excel, Outlook); experience with electronic documentation systems is a plus.