Regulatory Compliance Specialist

Job Title: Regulatory Compliance Specialist Location: Lower Gwynedd Township, PA 19002Duration: 12 MonthsQualifications:• Education: Bachelor's degree in Quality Assurance, Engineering, Chemistry, Biology, Compliance, or related field. Formal Quality Training is a plus.• Experience: Minimum 10 years in compliance, regulatory affairs, or related field. Extensive knowledge of FDA regulations (21CFRs) and compliance concepts.• Skills: Attention to detail, experience in compliance audits, investigations, risk assessments, and training programs. Strong analytical, problem-solving, communication, and interpersonal skills. Proficiency in compliance software tools and systems (Excel, Word, PowerPoint, Outlook, LIMS).Responsibilities:• Conduct compliance audits of records and lab systems.• Maintain detailed auditing records and prepare trending reports.• Monitor auditing results to support data integrity and compliance.• Contribute to performance improvement projects.• Serve as the department's compliance expert, supporting regulatory and accreditation survey activities.• Develop and implement audit and documentation policies and procedures.• Perform data analysis to generate metrics and track compliance trends.• Provide training on compliance processes and best practices.