Quality Assurance Associate

Description

BioStem Technologies, founded in 2014 and located in South Florida, is a leading medical technology company focused on advanced wound care and regenerative medicine. We develop and commercialize placental tissue allografts, cutting-edge wound care products, and surgical solutions aimed at improving patient outcomes. As we continue our rapid growth and expansion, we seek a Quality Assurance Associate to join our Quality Team. 

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.

Essential Duties and Responsibilities

Include but are not limited to the following, other duties may be applied;

• 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.

Requirements

Required 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.
• 0–2 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. 

About BioTissue & our Culture

At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.

Purpose led us here. Passion and legacy keep us going.

BioStem Technologies, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.