BioTissue Ocular · 3 days ago
Associate I, Quality Assurance
Miami, FL, US
Full-time
Onsite
New Grad, Entry LevelBioTissue Ocular is a company focused on quality assurance in the ocular sector. 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.
Biotechnology
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
Qualification
Required
High School diploma or equivalent GED
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
Preferred
Four-year college degree or equivalent Quality experience
Working knowledge in ERP software applications
Working knowledge in QMS software applications
Company
BioTissue Ocular
BioTissue Ocular is the pioneer and leader in regenerative medicine for ocular surface disease.
Founded in 2001
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase