Job Description

Job Overview : The Quality Inspector I will play a critical role in ensuring that all amniotic membrane tissue products meet stringent quality standards throughout the processing and packaging stages. This includes inspecting tissue products for integrity, verifying compliance with regulatory standards, and ensuring proper documentation. The position requires a strong attention to detail and a commitment to following standard operating procedures (SOPs).

Essential Functions :

Inspection :

• 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.

Documentation and Reporting :

• 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.

Compliance and Regulatory Adherence :

• 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.

Process Improvement :

• 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.

Training and Support :

• 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.

Team Collaboration and Support :

• 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.

Qualifications:

• High school diploma or equivalent required. A degree in biological sciences, medical technology, or a related field is preferred.
• Familiarity with tissue processing, especially amniotic membrane or other human tissue, is an asset.
• Strong attention to detail with the ability to identify quality issues and defects in tissue products.
• Basic computer skills, ERP experience is a plus, but not required.
• Strong communication and collaboration skills.

* This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

Location : On-Site – Mesa, AZ

What we offer:

Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

Total Rewards Package :

• Competitive Salaries
• Health, Dental, and Vision Insurance
• Retirement Plans
• Tuition Reimbursement
• Generous Paid Time Off
• Employee Assistance Program
• No premium payments

BioLab Sciences is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.

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