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BioLab Holdings · 21 hours ago

Quality Inspector II

Mesa, AZ

Full-time

Onsite

New Grad, Entry Level

BioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. The Quality Inspector II will ensure that all amniotic membrane tissue products meet stringent quality standards throughout the processing and packaging stages, including inspecting products for integrity and verifying compliance with regulatory standards.

BiotechnologyMedical

Hiring Manager

Hannah Levos

Responsibilities

Inspect and assess amniotic membrane tissues throughout the processing stages, from processing to final packaging and returns

Inspect tissue items to evaluate characteristics such as packaging, labeling, and integrity of the sterile barrier for returns

Verify that tissue packaging and labeling adhere to standardized SOPs and meet regulatory requirements

Perform visual inspections to ensure products are free from defects and meet all quality criteria before being finalized as finished goods

Document all inspection activities, including inspection results, deviations, and corrective actions, in compliance with Good Manufacturing Practices (GMP) and regulatory standards

Maintain accurate records of inspections and quality control activities to ensure traceability

Prepare and submit reports regarding quality inspection findings and any non-conformances

Ensure all procedures align with FDA, AATB (American Association of Tissue Banks), and other relevant regulations for tissue processing

Assist in preparing for audits and inspections by regulatory bodies, providing requested documentation and information

Stay updated on relevant industry regulations and best practices to ensure compliance

Collaborate with the team to identify areas for improvement in quality control processes and tissue handling procedures

Recommend process adjustments or corrective actions to improve product quality and efficiency

Investigate and report any quality-related issues or tissue integrity concerns

Provide training to team members on quality inspection procedures, safety protocols, and compliance standards

Support the integration of new technologies into the quality control system to enhance productivity and accuracy

Contribute to the development and improvement of SOPs and inspection processes

Work closely with packaging and shipping teams to ensure product quality is maintained throughout production and shipping

Proactively communicate discrepancies or issues found during inspections to ensure corrective actions are taken

Support the Quality team with tasks such as donor chart reviews, handling complaints, and participating in corrective actions (CAPAs) or non-conformance reports (NCRs)

Participate in other quality-related tasks as assigned

Qualification

Tissue processingQuality inspectionRegulatory complianceManufacturing PracticesBasic computer skillsAttention to detailCommunication skillsCollaboration skills