Job Description: Join our Laboratory Services Group as a Quality Assurance Specialist, where you will oversee laboratory investigations, deviation reports, and change controls across Chemistry, Microbiology, and Spray laboratories. This role ensures compliance with cGMP and company procedures, requiring minimal supervision. You will review analytical procedures, instrument qualifications, Standard Operating Procedures (SOPs), and methods, while reporting quality metrics and trends in investigations.
Responsibilities:
Review investigations, Change Control Requests, SOPs, and Analytical Methods.
Make quality decisions aligned with cGMP, regulatory compliance, and site SOPs.
Conduct gap analysis of quality procedures to ensure completeness.
Collaborate with departments and customers to address comments on Investigations and Deviations.
Ensure timely revision and approval of investigations.
Review and approve methods, Document Change Notices, and applicable SOPs for the QA Laboratory Services group.
Assist in document retrieval during audits.
Provide training on the effective use of the Trackwise system.
Maintain and report quality metrics and investigation trends.
Review documents for compliance with company standards.
Support management with additional tasks as needed.
Review and approve cGMP documentation related to QA Laboratory Services Group functions.
Communicate project information to assist with timelines.
Lead process improvements and projects within the company.
Qualifications:
Bachelor's degree in Chemistry or Biology required.
Preferably 3-4 years of relevant experience in the pharmaceutical industry, focusing on writing laboratory investigations, GMP documentation review, Quality Systems, and Health Authority Regulations.