COMPLIANCE SPECIALIST

1. Bachelor’s degree in chemistry, Microbiology, Engineering or similar STEM discipline highly preferred. 2. A minimum of 3 to 5 years of experience in quality assurance or regulatory affairs within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). 3. Knowledge of federal, state, and local regulatory requirements, including FDA CFRs, DEA, and Pharmacopeia standards. 4. Preferred knowledge in LIMS, and Quality Management Systems (for example TrackWise, TruVault). 5. Proven experience in managing both internal and external audits, including preparing for and responding to audit findings. 6. Strong understanding of regulatory requirements and quality management systems in a regulated industry. Excellent analytical and problem-solving skills with experience in deviation analysis and root cause analysis. 7. Effective communication and leadership skills to facilitate client meetings and cross-department collaboration. 8. Proficiency in managing audits, investigations, and corrective/preventive actions. 9. Ability to develop and maintain compliance tracking systems and procedural controls. 10. Experience in validation protocol creation and review is a plus.

1. Ensures that an organization adheres to all regulatory requirements and internal quality standards. 2. Developing, implementing, and maintaining compliance programs, policies, and procedures to meet industry regulations and quality standards in adherence to regulations and client’s requirements. 3. Conduct regular audits, inspections, and risk assessments to identify areas for improvement and ensure adherence to standards. 4. Works closely with various departments to provide guidance on compliance issues, investigates potential non-compliance or violations, and implements corrective actions. 5. Responsible for staying updated on relevant regulations and ensuring continuous improvement in quality processes while minimizing compliance risks. 6. Lead training sessions to educate staff on regulatory changes and best practices in quality assurance. 1. Develop and maintain a robust system for tracking overall services compliance, ensuring all processes adhere to regulatory standards and client requirements. 2. Conduct thorough evaluations to determine the product and regulatory impact of Minor and Major Deviations, providing detailed reports and recommendations. 3. Assess current procedural controls and recommend improvements. 4. Lead and facilitate meetings with clients to discuss investigation outcomes and findings. 5. Lead the investigation, documentation, and resolution of Minor and Major Deviations. Develop and implement Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence. 6. Oversee all regulatory aspects, including managing external and internal audits, investigations, and corrective/preventive actions. 7. Participate in Root Cause Analysis, Human Performance Analysis, and Process Mapping meetings to support the resolution of Major Deviations. 8. Assist in the creation, review, and training for Validation Qualifications and Protocols. 9. Ensure compliance with international, federal, state, and local regulatory requirements (e.g., FDA CFRs, DEA, other regulatory agencies) as well as customer-specific requirements. 10. Work closely with internal departments to achieve compliance with industry and customer expectations, driven by customer goals to maintain KPIs. 11. Ensure all employees adhere to standard operating procedures (SOPs) established by clients and internal MTG procedures.