Compliance Officers

Job Description:

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

Responsibilities:

• Act as a liaison for ethics and compliance support, adhering to critical business activities within our US market.
• Execute and manage paper, field, and program auditing and monitoring activities.
• Organize and evaluate facts and evidence to 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.
• Follow up with key stakeholders for implementation.
• Assist in the development of periodic reporting of results to senior management.
• Maintain the company's commercial compliance policies and procedures.
• Evaluate internal policies, standards, and procedures against external laws and regulations.
• Monitor state and federal regulations affecting pharmaceutical personnel.
• Report on upcoming changes in federal and/or state laws.
• Conduct regular compliance inspections.
• Ensure the effectiveness of compliance systems.
• Distribute standardized internal communications on important compliance developments.
• Assist with investigations of alleged violations of compliance policies, laws, regulations, or procedures.
• Perform GAP Analyses for new/revised Corporate and Division documents.
• Implement changes as appropriate.
• Support all state, federal & regulatory inspections and information requests.
• Prepare compliance training for company employees.
• Support the preparation, revision, and implementation of relevant SOPs.

Requirements:

• Bachelor's degree in science, engineering, quality, or another technical field, or high school diploma with a minimum of 4 years of experience.
• A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.

Benefits:

• 401K plan with employer match and immediate vesting.
• Medical, Vision, Life, and Dental Insurance.
• Pet Insurance.
• Company paid STD and LTD.
• Company Paid Holidays.
• Three Weeks' Paid Time Off (within the first year).
• Tuition Assistance (after the first year).