Job Description: Quality Compliance Specialist Maintain and improve product quality by completing product, company, quality system, and compliance audits. Work through deviations, out-of-specifications (OOS), change controls system, Quality Management System (QMS), quality agreements, and Vendor Qualifications. Manage Drug Master Files (DMFs), Veterinary Master Files (VMFs), and respond to regulatory bodies. Ensure compliance with global Good Manufacturing Practice (GMP) requirements throughout all phases of product development and commercialization. Plan and conduct internal and external audits, regulatory agency inspections, and negotiate and implement quality agreements. Review and approve batch records, support Quality Assurance, and handle documentation review and approval. Approve, release, reject, or hold raw materials, packaging, and finished product along with labeling. Author or edit Standard Operating Procedures (SOPs) and handle investigations related to deviations and customer complaints. Provide information and documentation responses for customer complaints or returns. Author, review, and approve equipment Installation Qualification (IQ), Operational Qualification (OQ) protocols, or other protocols. Ensure plant-wide compliance with cGMP regulations and conduct cGMP training for all levels of employees. Assist Purchasing by executing raw material and new customer evaluations. Lead internal compliance inspections including schedule maintenance, plant and lab inspections, report writing, and follow-up. Lead external compliance audits including schedule maintenance, external supplier inspections, report writing, and follow-up. Hard Skills + Compliance + Audit + Pharmaceutical + GMP requirements + Batch record review + Quality Assurance + SOP authoring + Regulatory response + Vendor Qualifications + Equipment IQ/OQ protocols 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.