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Compliance Associate

2 months ago

Boca Raton, United States Brightpath Associates LLC Full time

Job Description

The Compliance Associate is responsible provides GxP (GMP/GLP/GDP) compliance oversight for the organization.


Qualifications:

  • Act 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.