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Job Description ADMA Biologics
is a biopharmaceutical company dedicated to developing superior products for immunodeficient patients at risk of infection. Our commitment to this underserved population drives our innovation and hands-on approach to production and development, setting us apart in the industry. If you're seeking a dynamic, innovative, and growing company in the biopharmaceutical sector that values excellence and integrity, consider joining ADMA Biologics. We currently have an exciting opportunity for a
Associate, Compliance located in
Boca Raton, FL ! Job Title: Associate, Compliance Job Description: Position Summary
The
Compliance Associate
is responsible provides GxP (GMP/GLP/GDP) compliance oversight for the organization. Essential Functions (ES) and Responsibilities
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. 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. 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. Supports all compliance responsibilities. Supports the preparation, revision, and implementation of relevant SOPs. Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detailAble to work in high-pressure, deadline-driven environmentDemonstrated ability to achieve goals, overcome obstacles, and meet deadlinesPossess time management skills and be able to balance multiple job assignments at oncePossesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendationsExperience Requirements
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. Promotional Review Committee (PRC) or Legal Medical Review (LMR) designation a plus. Experience Requirements:
A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry. Must have experience acting as a liaison for ethics and compliance support adhering to critical business activities within the US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others. Must have conducted a minimum of 2 to 3 external/field commercial audits. Preferred Experience Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Job Description Footer: 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.
Company
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
Company info Website http://www.admabiologics.com/ Phone 201-478-5222 Location 5800 Park of Commerce Blvd. NW Boca Raton, FL 33487 US
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Job Description ADMA Biologics
is a biopharmaceutical company dedicated to developing superior products for immunodeficient patients at risk of infection. Our commitment to this underserved population drives our innovation and hands-on approach to production and development, setting us apart in the industry. If you're seeking a dynamic, innovative, and growing company in the biopharmaceutical sector that values excellence and integrity, consider joining ADMA Biologics. We currently have an exciting opportunity for a
Associate, Compliance located in
Boca Raton, FL ! Job Title: Associate, Compliance Job Description: Position Summary
The
Compliance Associate
is responsible provides GxP (GMP/GLP/GDP) compliance oversight for the organization. Essential Functions (ES) and Responsibilities
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. 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. 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. Supports all compliance responsibilities. Supports the preparation, revision, and implementation of relevant SOPs. Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detailAble to work in high-pressure, deadline-driven environmentDemonstrated ability to achieve goals, overcome obstacles, and meet deadlinesPossess time management skills and be able to balance multiple job assignments at oncePossesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendationsExperience Requirements
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. Promotional Review Committee (PRC) or Legal Medical Review (LMR) designation a plus. Experience Requirements:
A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry. Must have experience acting as a liaison for ethics and compliance support adhering to critical business activities within the US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others. Must have conducted a minimum of 2 to 3 external/field commercial audits. Preferred Experience Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations. Job Description Footer: 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.
Company
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
Company info Website http://www.admabiologics.com/ Phone 201-478-5222 Location 5800 Park of Commerce Blvd. NW Boca Raton, FL 33487 US
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