What are the responsibilities and job description for the Compliance Associate position at Brightpath Associates LLC?
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.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Free Shuttle to the Boca Tri-Rail station
