ADMA Biologics, Inc.
Specialist QA II Manufacturing Oversight
ADMA Biologics, Inc., Boca Raton, Florida, us, 33481
Overview
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. We are seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. Job Title
Specialist QA II Manufacturing Oversight Responsibilities
Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports (CAPAs), Change Controls, and Out of Specifications (OOSs)). Perform Quality Assurance review and approval of Deviation Reports. Possess an understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600. Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies. Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required. Review and release of Plasma pools to manufacturing. Review all manufacturing support documentation (logbooks, log sheets, charts, etc.). Review and release of raw materials in LIMS/SAP. Perform audits of Nitrogen receipt process. Perform notification and disposition of associated Lookback units. Assist with quarantining and release of critical systems, equipment, and controlled environments. Write, review, and revise QA SOPs. Review SOPs and documents from other departments and provide feedback as necessary. Work with other departments to assess if Deviations, CAPAs, and Change Controls are required. Assist with training of new employees. Coordinate and perform any additional activities or projects assigned by QA Management. Experience with LIMS and SAP preferred. Job Requirements
Qualifications
Exceptional organizational and communication skills. Must have excellent writing and oral skills. Education Requirements
Bachelor's Degree preferred but can be offset by experience. Experience Requirements
3-5 years' experience in pharmaceutical or biotechnology industry or other related industry. Preferred Experience
Compliance Requirements (ES): As part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures should be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Benefits
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 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 Job Function
Quality Assurance Seniority Level
Mid-Senior level Employment Type
Full-time Note: This description reflects the current responsibilities and requirements for the Specialist QA II Manufacturing Oversight role and may be subject to change.
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ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. We are seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. Job Title
Specialist QA II Manufacturing Oversight Responsibilities
Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports (CAPAs), Change Controls, and Out of Specifications (OOSs)). Perform Quality Assurance review and approval of Deviation Reports. Possess an understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600. Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies. Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required. Review and release of Plasma pools to manufacturing. Review all manufacturing support documentation (logbooks, log sheets, charts, etc.). Review and release of raw materials in LIMS/SAP. Perform audits of Nitrogen receipt process. Perform notification and disposition of associated Lookback units. Assist with quarantining and release of critical systems, equipment, and controlled environments. Write, review, and revise QA SOPs. Review SOPs and documents from other departments and provide feedback as necessary. Work with other departments to assess if Deviations, CAPAs, and Change Controls are required. Assist with training of new employees. Coordinate and perform any additional activities or projects assigned by QA Management. Experience with LIMS and SAP preferred. Job Requirements
Qualifications
Exceptional organizational and communication skills. Must have excellent writing and oral skills. Education Requirements
Bachelor's Degree preferred but can be offset by experience. Experience Requirements
3-5 years' experience in pharmaceutical or biotechnology industry or other related industry. Preferred Experience
Compliance Requirements (ES): As part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures should be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Benefits
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 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 Job Function
Quality Assurance Seniority Level
Mid-Senior level Employment Type
Full-time Note: This description reflects the current responsibilities and requirements for the Specialist QA II Manufacturing Oversight role and may be subject to change.
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