Job Title: GLP QA AuditorJob Description We are seeking a highly skilled GLP QA Auditor to lead the planning, conducting, and reporting of GLP audits. The role involves independently managing GLP audits, assessing vendor compliance, and supporting regulatory inspections. You will play a key role in ensuring compliance with GLP regulations and maintaining the highest quality standards. Responsibilities + Independently lead the planning, conducting, and reporting of assigned GLP QA routine and non-routine audits, including facilities, equipment, personnel, methods, practices, records, and controls. + Assess vendors for GLP compliance and monitor studies conducted at these vendors. + Submit periodic written status reports to management and the study director, highlighting any issues encountered and corrective actions taken. + Review final study reports to ensure they accurately reflect the methods, standard operating procedures, and raw data from the nonclinical laboratory study. + Prepare and sign a statement to accompany the final study report, detailing the dates of inspections and findings reported to management and the study director. + Perform risk-based quality review content by utilizing reports to assess missing documents and monitor progress in resolving identified study plan/report discrepancies. + Provide daily support for the data integrity and GLP quality assurance program for Preclinical studies, Clinical studies (samples), as well as Analytical Chemistry/Material Characterization. + Assist in the preparation and presentation of audit training materials and support the development and mentorship of other auditors. + Ensure standard procedures, audit tools, and plans are fully understood and applied in audit activities. + Prepare and present audit reports reflecting operating information, audit results, and findings. + Analyze and interpret data to identify patterns and trends. + Ensure timely and appropriate review and delivery of CAPAs and actions arising from audits. + Communicate information logically and concisely, verbally and in written reports. + Support other auditors in planning, conducting, and reporting audits. + Support regulatory inspections in a lead or supporting role and conduct pre-inspection visits and document preparation. Essential Skills + Bachelor's degree in a scientific, pharmaceutical, medical, or related field required; advanced degree preferred. + Minimum of 3 years of experience in Quality & Compliance and/or related R&D area. + Knowledge of Good Laboratory Practices (GLP) and applicable regulations/guidelines (e.g., FDA regulations, OECD Principles of GLP, EU Directive; 2004/23/EC and EU General Data Protection Regulation (GDPR)). + Experience using standard applications/systems; data analytics tools preferred. + Excellent networking, communication, organization, investigation, and negotiation skills. + Ability to effectively negotiate and influence upper management, affiliates, and Regulatory Agencies. + Creative thinking relative to new and emerging technologies and analytics. + Inspection support experience (OECD, FDA, EMA, and other inspectorates). + Ability to plan and prioritize work efficiently and work well under time constraints. + Willingness to travel up to 20%, primarily in the US. Additional Skills & Qualifications + Experience with external vendor audit leadership, preferably as the lead auditor. + Experience conducting GLP audits and audits of clinical lab samples for human trials and non-clinical lab samples on animals. + Ability to support Pre/Post Acquisition activities. + Proficiency in analyzing and interpreting data and identifying patterns and trends. + Experience in ad-hoc consulting, internal audit, and quality assurance. Work Environment This role is remote-based in the US, with flexible and part-time workload based on the audit schedule and candidate availability. The workload involves ad-hoc consulting, with per-audit workload approximately 50-60 hours over 6-8 weeks. Travel time is compensated if required, with at least 3 GLP audits expected between Q2-Q4 of this year. There is potential for additional work based on interest and availability. Pay and Benefits The pay range for this position is $60.00 - $70.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position will be accepting applications until Jan 16, 2025. 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.