Compliance Associate

4 weeks ago

Boca Raton, United States ADMA Biologics Inc Full time

Job Details

Job Location: ADMA Biologics - Boca Raton, FL

Position Type: Full Time

Education Level: 4 Year Degree

Salary Range: Undisclosed

Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Compliance Associate in Boca Raton, Florida

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 ADMA's 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

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer. #J-18808-Ljbffr

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