Job Description:

Summary: The Quality Assurance Specialist will be a member of the Diagnostic Services Unit, responsible for overseeing all lab investigations, deviation reports, and change controls across a variety of different departments to ensure compliance with cGMP and company procedures.Key Responsibilities:Evaluate investigations, Change Control Requests, Standard Operating Procedures, and Analytical Methods.Demonstrate the ability to make quality decisions based on cGMP, regulatory compliance, and site SOPsdocumentation.Conduct gap analysis of all quality-related procedures to ensure completeness.Collaborate with other departments and customers to address feedback on Investigations and Deviations.Work with departments to ensure timely revisions and approvals of investigations.Assist in document retrieval during audits.Provide training to ensure proficient use of the Trackwise system.Maintain and report on quality metrics and trends in investigations.Review documents to ensure compliance with company standards for formatting, review, approvals, and implementation.Lead process improvement initiatives and projects within the company.Qualifications:Bachelor's degree in Chemistry or Biology required.Preferably at least 3 to 4 years of relevant experience in the pharmaceutical industry, with a focus on writing laboratory investigations and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.