Regulatory Compliance Specialist

Join Our Dynamic Team as a Regulatory Compliance Document Specialist! Are you passionate about ensuring excellence in regulatory compliance within a fast-paced environment? We are seeking a dedicated and detail-oriented Regulatory Compliance Specialist to support and maintain our organization's compliance functions in a 24/7 high-speed atmosphere. The focus of the position is to support the performance and hosting of audits, update and revision of policies and procedures, completion of investigations and CAPAs, processing of change controls, management of documents, handling and investigation of customer complaints, and performance, management and recording of training. SPECIALIST RESPONSIBILITY The Regulatory Compliance Specialist position is responsible for the support and maintenance of regulatory compliance functions for the organization in a 24/5 high speed atmosphere. Reports to the Senior Manager, Regulatory Compliance. Position Overview The Regulatory Compliance Specialist plays a key role in identifying gaps in programs or processes and assuring the QA team assists in closing those gaps. Main responsibilities include: Responsible for assisting the oversight and management of regulatory compliance functions for the site. Understanding of various Quality system regulations (21 CFR Part 111, 210, 211, 820, 4) as well as the ICH Guidelines. Support the Quality Management System (QMS): audits, policies and procedures, investigations and CAPAs, change controls, document management, customer complaints and training. Ensures compliance of the Quality Management System (QMS) in accordance with local, federal, state regulations and client and company requirements. Manage support to the company during regulatory and client inspections/audits. Manages the site’s certification programs (UL, USP, Halal, Kosher, Organic, Gluten-Free, etc.). Responsible for assisting in scheduling and execution of the site internal auditing program and assuring CAPAs are completed in a timely manner. Support the facility’s supplier auditing program. Manages archival of GMP documentation for the site. Actively participate in company continuous improvement initiative. Able to work in an environment of rapidly changing priorities and workload. General support to all Quality Assurance functions across the organization. Qualifications B.S. degree or other related 2-5 years QA experience in a regulated industry. Knowledge/experience in conducting quality system assessments for manufacturing/packaging locations and suppliers. Knowledge of packaging systems. Excellent computer skills, to include spreadsheet, database, and word processing applications. Excellent verbal and written communication skills. This individual must have the ability to share their technical knowledge with others in a coaching environment to ensure compliance with Nutra-Med SOP’s. Why Join Us? We offer a collaborative work environment where your contributions make a significant impact. You'll have the opportunity to work with a team dedicated to maintaining the highest standards of quality and compliance. We value continuous improvement and support professional growth and development. Equal Employment Opportunity Statement Nutra-Med Packaging, LLC., is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. We make hiring decisions based solely on qualifications, merit, and business needs at the time. #J-18808-Ljbffr Nutra-Med Packaging LLC