Pharma Compliance Associate

Job DescriptionThe Compliance Associate is responsible provides GxP (GMP/GLP/GDP) compliance oversight for the organization.QualificationsAct as a liaison for ethics and compliance support adhering to critical business activities within our US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others.Execute and help manage paper, field, and program auditing and monitoring activities.Organize and evaluate facts and evidence and draw sound conclusions in relation to auditing and monitoring activities and processes.Maintain audit files, evidence, and other records.Prepare timely, accurate, and complete reports with corrective action recommendations and follow-through with key stakeholders for implementation.Assist in the development, preparation, and management of periodic reporting of results to senior management.Assist in the maintenance of compliance program, including, but not limited to, the company's commercial compliance policies and procedures.Ensure compliance with internal policies, standards and procedures and external laws and regulations including environmental health and safety programs for the company.Monitor all state and federal regulations affecting pharmaceutical personnel and report on upcoming changes in federal and/or state laws.Prepare and conduct regular compliance inspections.Monitor compliance systems to ensure their effectiveness.Compose and disseminate standardized internal communications to personnel on important compliance developments, company policies, and procedures.Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures.Ensure adequate GAP Analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate.Assists with all state, federal & regulatory inspections and information requests.Assist in the preparation of compliance training for company employees.Supports all compliance responsibilities. Supports the preparation, revision, and implementation of relevant SOPs.Actively participates in continuous improvement programs to align with business strategies.Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance.Education Requirements:Bachelor's degree in science, engineering, quality or another technical field or high school diploma with a minimum of 4 years of experience is required.Experience Requirements:A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree Shuttle to the Boca Tri-Rail station

Created: 2025-03-10