ADMA Biologics, Inc.
Compliance Associate
ADMA Biologics, Inc., Boca Raton, Florida, us, 33481
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 for providing 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.Assist with all state, federal & regulatory inspections and information requests.Assist in the preparation of compliance training for company employees.Support all compliance responsibilities. Support the preparation, revision, and implementation of relevant SOPs.Actively participate 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 stationADMA 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
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 for providing 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.Assist with all state, federal & regulatory inspections and information requests.Assist in the preparation of compliance training for company employees.Support all compliance responsibilities. Support the preparation, revision, and implementation of relevant SOPs.Actively participate 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 stationADMA 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