Job Details: Job Location: Tamarac Aveva - Tamarac, FL, Position Type: Full Time, Salary Range: $50000.00 - $60000.00Salary, Job Shift: Day, About Us: Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. Job Summary: The Compliance Specialist is responsible for overseeing critical aspects of the organization's quality management systems, including Change Control, Corrective and Preventive Actions (CAPA), Production Supplies Supplier Qualification Program, Annual Product Review and participation in the Quality Council. This role ensures that all compliance activities align with regulatory requirements and internal policies, supporting continuous improvement initiatives. The Compliance Specialist will play a key role in ensuring that processes are compliant, efficient, and effective in maintaining the organization's overall quality standards. Job Responsibilities:  Change Control Management: Oversee and manage the Change Control process to ensure compliance with regulatory standards (e.g., FDA, ISO, GMP). Review and track change requests, ensuring proper documentation, risk assessments, and evaluations of potential impacts on product quality and compliance. Monitor the implementation of approved changes, ensuring adherence to timelines and regulatory requirements. Corrective and Preventive Actions (CAPA): Oversee and manage the CAPA process in response to findings from regulatrory inspections, customer audits, and internal audits to ensure compliance with regulatory standards (e.g., FDA, ISO, GMP). Monitor the implementation and approval of audit- related CAPAs o ensure timely completion and appropriate resolution of identified findings. Maintain accurate CAPA records and generate reports for senior management and regulatory authorities, as applicable. Production Supplies Qualification Program Oversight: Ensure that supplier systems comply with all applicable regulations and quality standards. Collaborate with procurement and quality teams to ensure proper supplier qualification, requalification, and the resolution of quality-related issues. oSupport the development and maintenance of Risk analysis, and quality agreements, if apply, and ensure alignment with regulatory and organizational standards. Quality Council Participation: Actively participate in the organization's Quality Council meetings, providing insights and recommendations related to compliance and quality management systems. Collaborate with cross-functional teams to drive continuous improvement initiatives and resolve systemic quality issues. Annual Product Review (APR) / Product Quality Review (PQR) Coordinate, prepare, review, and maintain Annual Product Reviews (APRs) for all commercial products in accordance with applicable FDA regulations, cGMP requirements, and established company procedure. Develop and maintain the annual APR schedule to ensure all commercial products are reviewed within the established timelines. Coordinate with cross-functional departments, including Quality Control, Quality Assurance, Manufacturing, Engineering, Warehouse, Regulatory Affairs, and Supply Chain, to collect and verify the data required for each product review.  Collect, compile, trend, and evaluate product and process quality data for the applicable review period. Evaluate the status and effectiveness of previously implemented CAPAs and corrective actions associated with product quality trends. Monitor APR completion and approval timelines, follow up on outstanding departmental inputs, and escalate delays as appropriate. Maintain approved APR/PQR reports and supporting documentation in accordance with document control and record-retention requirements. Documentation and Reporting: Maintain and manage all compliance-related documentation, including Change Control records, CAPA reports, supplier quality, and Quality Council meeting minutes. Ensure that documentation is up-to-date, accurate, and readily available for review by internal and external stakeholders. Generate and present regular compliance reports, including key performance indicators (KPIs), for senior management and regulatory bodies. Works as a member of a team to achieve all outcomes. Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements; Delivers all work in support of our Values of Innovate, Excel, and Evolve; All other duties as assigned. Qualifications: Education: Bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related field. Advanced certifications (e.g., ASQ, Six Sigma, or GxP) are a plus. Experience: Minimum of 3-5 years of experience in compliance or quality assurance within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). Solid understanding of Change Control, CAPA processes, supplier quality management, and participation in cross-functional teams such as a Quality Council. Knowledge of regulatory standards such as FDA, ISO 13485, cGMP, and other applicable guidelines. Knowledge, Skills and Abilities Strong attention to detail with excellent problem-solving and analytical abilities. Proven ability to manage multiple priorities, meet deadlines, and handle complex compliance issues. Proficient in Microsoft Office Suite and quality management software (e.g., TrackWise, Veeva Vault, MasterControl). Strong communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and management. Benefits Aveva Drug Delivery Systems and DifGen Pharmaceuticals offer a comprehensive benefits plan, including: Medical, Dental, and Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday   Equal Opportunity Employer