Associate I, Quality Assurance

BioTissue Holdings Inc

5h

About The Position

The Associate I, Quality Assurance is responsible for supporting the finished product release process and ensuring that all products meet established quality standards prior to distribution. This role includes reviewing product documentation, assessing compliance with cGMP requirements, and coordinating with cross‑functional teams to ensure the timely and accurate disposition of finished goods. The incumbent will also assist with various Quality department activities, including manual and electronic documentation management, data entry, and document creation. This position requires close collaboration with GMP/GTP‑related departments such as Production, Supply Chain, Facilities, and Distribution to maintain compliance and operational efficiency.

Requirements

• Strong verbal and written communication skills with the ability to work effectively across all levels and functions within the organization.
• Excellent organizational, documentation, and record‑keeping abilities.
• High attention to detail with strong analytical and problem‑solving skills.
• Ability to work both independently and collaboratively in a fast‑paced, regulated environment.
• Proficient in Microsoft software applications: Excel, Word, PowerPoint, and Outlook.
• Minimum: High School diploma or equivalent GED.

Nice To Haves

• Working knowledge in ERP software applications (preferred).
• Working knowledge in QMS software applications (preferred).
• Excellent organizational skills
• Preferred: Four-year college degree or equivalent Quality experience.

Responsibilities

• Review executed Batch Records for In-process and final products, ensuring accuracy, completeness, and compliance with cGMP requirements and internal policies.
• Evaluate product documentation and test results to determine acceptability for final product release.
• Perform disposition activities for finished goods in accordance with approved procedures.
• Collaborate with Supply Chain and Manufacturing, to support efficient, on-time product release.
• Execute containment activities for materials impacted by ongoing investigations.
• Review microbiological testing results, including Bioburden and Environmental Monitoring data, for compliance and release suitability.
• Manage the physical and electronic movement of materials between quarantine and released inventory locations.
• Conduct periodic inventory cycle counts and reconcile physical versus electronic inventory records.
• Serve as a liaison with external laboratories to ensure timely receipt of donor testing and environmental monitoring results.
• Train new team members, support cross‑training initiatives, and conduct competency assessments.
• Assist in the development, revision, and review of SOPs, Work Instructions, forms, and Batch Records to ensure compliance with cGMPs, applicable standards, and internal policies.
• Provide updates to Quality and Operations management regarding batch status, pending releases, and potential delays.
• Participate in continuous improvement initiatives by identifying process enhancements related to product review and release activities.
• Perform administrative duties in support of GMP operations, including filing, copying, scanning, shredding, and archiving quality documents.
• Perform additional duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED