Quality Assurance Inspector I

The Quality Assurance Inspector is responsible for executing on a comprehensive and effective internal auditing program compliant with Standard Operating Procedures in addition to FDA, AATB, and State regulations and standards. This role also performs routine checks and verifications of the different elements of the quality system to ensure the Operation is meeting the company’s quality standards.

Duties and responsibilities

• Assist in the development of the internal audit schedule.
• Draft audit reports to communicate the outcomes to the corresponding management staff.
• Perform recurrent inspections of the different departments to ensure the quality systems is in compliance with internal procedures, accrediting body standards, and local and federal regulations.
• Perform routine verification of quality systems including but not limited to environmental monitoring, facility sanitization, sterilization records, incoming material inspections, and product returns.
• Perform other duties as assigned by QA management.

Education Required:  Bachelor degree in Life Sciences or equivalent required.

Experience:     1-2 years of experience in a quality assurance auditing role preferred.  Knowledge of  cGXP requirements in the tissue, medical device, biologics, or pharmaceutical industries.

Skills: The Quality Assurance Inspector must have strong verbal and written communication skills.

Licenses/Certifications: CTBS or ASQ certification preferred.

Working conditions

The job is performed in a quiet office environment; however, the majority of time will be spent inspecting processes on-site while interacting and engaging with employees to support business operations. The job requires work to be performed inside the cleanroom processing area where the person would be exposed to tissue processing.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time.  The employee may occasionally be required to pull, lift, and/or move up to 25 pounds.

Direct reports

No direct reports.