BioSpace
Job Description
ADMA Biologics
is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. 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
Specialist QA I Product Release .
Job Title:
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 logs, charts, specifications, and environmental and water for injection (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 Requirements / Competencies
Ability to follow the cGMPs and procedures with great attention to detail.
Demonstrated ability to use computer software including Microsoft Outlook, Word and Excel.
Strong organizational, interpersonal and collaborative skills; written and oral communication skills.
Education & Experience
Education:
Bachelor’s Degree, or years of experience in lieu of degree.
Experience:
Three to five years in pharmaceutical or biotechnology industry or other related industry.
Preferred Compliance 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. The role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Benefits
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid Short-Term Disability (STD) and Long-Term Disability (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 employment eligibility for all newly hired employees
Equal Opportunity Employer (EOE)
Note: This description reflects the current job requirements and is subject to change. No other sections or extraneous content are included.
#J-18808-Ljbffr
is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. 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
Specialist QA I Product Release .
Job Title:
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 logs, charts, specifications, and environmental and water for injection (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 Requirements / Competencies
Ability to follow the cGMPs and procedures with great attention to detail.
Demonstrated ability to use computer software including Microsoft Outlook, Word and Excel.
Strong organizational, interpersonal and collaborative skills; written and oral communication skills.
Education & Experience
Education:
Bachelor’s Degree, or years of experience in lieu of degree.
Experience:
Three to five years in pharmaceutical or biotechnology industry or other related industry.
Preferred Compliance 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. The role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Benefits
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid Short-Term Disability (STD) and Long-Term Disability (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 employment eligibility for all newly hired employees
Equal Opportunity Employer (EOE)
Note: This description reflects the current job requirements and is subject to change. No other sections or extraneous content are included.
#J-18808-Ljbffr