Quality Inspector I

## Description BioLab Holdings is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact. **** **** **Position Summary** **** **The Quality Inspector I** supports the Quality team by performing routine inspections of amniotic membrane tissue products throughout processing and packaging to ensure compliance with established quality standards and procedures. This role focuses on following defined Standard Operating Procedures (SOPs), accurately documenting inspection results, and escalating issues as identified. The position requires strong attention to detail, reliability, and a willingness to learn within a regulated manufacturing environment. **** **Essential Functions** **** **Inspection**: · Perform routine incoming inspections of supplies/materials used in manufacturing of amniotic membrane tissue products · Assist with routine inspections of returned amniotic membrane tissue products, which includes integrity of the sterile barrier under established SOPs. · Inspect tissue items for packaging accuracy, labeling correctness and verify that tissue packaging and labeling meet documented specifications and quality requirements. · Conduct visual inspections to identify obvious defects and document all findings on quality documentation · Escalate inspection findings, discrepancies, or potential quality issues to senior Quality team members or management. · Assist with ensuring products meet defined acceptance criteria prior to performing final release to finished goods. · Assist in quarantining amniotic membrane tissue products and/or supplies and releasing when deemed acceptable **Documentation and Reporting**: · Accurately document inspection activities and results in accordance with GMP and internal documentation requirements. · Maintain clear and complete inspection records to support product traceability. · Assist with the preparation of inspection-related documentation and reports, as directed. ~~~~ **** **Compliance and Regulatory Adherence**: · Follow FDA, AATB, and internal regulatory requirements applicable to tissue processing and inspection activities. · Support audit and inspection readiness by maintaining accurate records and providing documentation upon request. · Participate in required training to remain compliant with applicable regulations and procedures. **** **Process Support:** · Follow established quality control processes and tissue handling procedures. · Identify and report potential quality concerns, deviations, or tissue integrity issues to the Quality team. · Support corrective and preventive actions (CAPAs) or non-conformance investigations by providing inspection data and documentation. **Training and Development:** · Complete onboarding and ongoing training related to quality inspection procedures, safety protocols, and compliance requirements. · Learn and apply new or revised SOPs as they are implemented. · Seek guidance from senior Quality team members to develop inspection skills and regulatory knowledge. **Team Collaboration and Support**: · Work closely with processing, packaging, and shipping teams to ensure product quality is maintained throughout operations. · Communicate inspection findings clearly and promptly to support timely resolution of issues. · Assist the Quality team with tasks such as donor chart reviews, complaint support, and other quality-related activities as assigned. · Perform additional duties as needed to support Quality department objectives. *This job description is not intended to be an exhaustive list of all duties, responsibilities, or* *qualifiations associ…