Quality Assurance Specialist III develops and implements company and regulatory quality standards in the manufacturing facility. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist III audits and reviews quality data according to existing documents and procedures. May need to develop policies or methods to improve quality check efficiency. Additionally, Quality Assurance Specialist III may require an associate degree or its equivalent. Typically reports to a manager. The Quality Assurance Specialist III contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. To be a Quality Assurance Specialist III typically requires 4 to 7 years of related experience.
Quality Assurance Specialist III Job Description Template
Our company is looking for a Quality Assurance Specialist III to join our team.
Responsibilities:
- Performs other duties as assigned;
- Support the change control program, and perform assessments as part of change and risk management;
- Participate in client and regulatory inspections;
- Write, execute, review and approve validation protocols, reports, and system lifecycle documents, as required;
- Support the qualification of process and facility equipment, analytical instruments, and computer systems, as well as cleaning and process validation;
- Assist with investigations, root cause analysis, and corrective and preventative action, as needed.
Requirements:
- D emonstrated attention to detail and excellent oral and written communication skills;
- Working knowledge of GxPs, Regulations (such as 21 CFR Part 11, 210, 211 & Annex 11, 15), and related industry standards (such as USP, ASTM);
- Experience with equipment, instrument, and system qualification, and process and/or cleaning validation;
- Experience performing quality reviews in regulated company, including change control.