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 an Specialist QA I Product Release.
Position Summary
Performs a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements. This role ensures that all batches meet specifications, are manufactured and packaged in accordance with validated processes and procedures and comply with cGMP and regulatory standards.
Essential Functions (ES) and Responsibilities
Understand the cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
Primary focus is to ensure that all batch releases at ADMA are performed in accordance with current approved Standard Operating Procedures (SOPs) and confirm that all supporting documents are received and compliant before release.
Attend scheduling meetings to coordinate material release priorities as needed
Communicate any potential delays in the release of batches for manufacturing or commercial distribution
Assist with investigation reports and Corrective and Preventive Actions (CAPA) in the Quality Management System (QMS) and participate in special projects as required
Perform review and remediation and support release of manufacturing batch records along with all manufacturing supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data.
Discuss fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed.
Review SOPs and documents in revision from other departments for accuracy and completeness.
Assist in failure investigations including support in the identification of root causes and corrective actions.
Job Responsibilities or Job Requirements
Competencies
Experience Requirements
Education Requirements: Bachelor’s Degree but will accept years of experience in lieu of degree.
Experience Requirements: Three to five years in pharmaceutical or biotechnology industry or other related industry.
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.
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.