Description: Position Summary: Reporting to the QA Manager or Co-CEO. The Sr. QA Specialist, is responsible for reporting and follow-through of all internal audits for Methods, Study Plans and Final Validations per GLP. Create, maintain, change, and archive all QAU’s Standard Operating Procedures, Forms, Memos, Documents and Scientific data per GCLP. Control all company documents and procedures are properly authorized and adhere to ‘US FDA GLP, 21 CFR 58’. Key Responsibilities: • Author/Review Standard Operating Procedures (SOPs) and Statistical Analysis Plans (SAP). • Writing and updating QA Standard Operating Procedures (SOPs), QA files, and QA audit log. • Plan, conduct and report inspections of the internal facilities. • Facilitate company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations. • Assure QA document inspection reports and any other supporting documentation or required records are processed and archived, as appropriate. • Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance. • Plan, conduct and report audits of external vendors to assess compliance with regulations, industry standards, and best practices • Identify regulatory compliance issues and provide regulatory support to departments. • Provide GLP and GCLP training. Additional Skills & Qualifications: Qualifications and Educational Requirements: • Bachelor’s degree or higher • 5+ years relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/ pharmaceutical industry or a combination of education and experience About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.