BioSpace
Job Title: Specialist QA I Product Release
ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients. We are looking for a dynamic, innovative professional to join our growing Quality Assurance team. Responsibilities
Perform a wide variety of Quality Assurance activities to ensure batch compliance with cGMP and regulatory standards. Review and confirm that all batch releases are performed according to approved SOPs and that supporting documents are complete and compliant before release. Attend scheduling meetings to coordinate material release priorities and communicate potential delays in batch releases. Assist with investigation reports and CAPA in the 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 WFI data. 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. Qualifications
Bachelor’s Degree in a relevant field (or equivalent experience). Three to five years of experience in the pharmaceutical, biotechnology, or related industry. Strong knowledge of cGMP regulations (21 CFR Parts 11, 210, 211, and 600) and quality systems (CAPAs, change controls, OOSs). Demonstrated ability to use computer software including Microsoft Outlook, Word, and Excel. Excellent written and oral communication, strong organizational, interpersonal, and collaborative skills. Benefits
401(k) 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). Easy access to the 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.
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ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients. We are looking for a dynamic, innovative professional to join our growing Quality Assurance team. Responsibilities
Perform a wide variety of Quality Assurance activities to ensure batch compliance with cGMP and regulatory standards. Review and confirm that all batch releases are performed according to approved SOPs and that supporting documents are complete and compliant before release. Attend scheduling meetings to coordinate material release priorities and communicate potential delays in batch releases. Assist with investigation reports and CAPA in the 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 WFI data. 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. Qualifications
Bachelor’s Degree in a relevant field (or equivalent experience). Three to five years of experience in the pharmaceutical, biotechnology, or related industry. Strong knowledge of cGMP regulations (21 CFR Parts 11, 210, 211, and 600) and quality systems (CAPAs, change controls, OOSs). Demonstrated ability to use computer software including Microsoft Outlook, Word, and Excel. Excellent written and oral communication, strong organizational, interpersonal, and collaborative skills. Benefits
401(k) 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). Easy access to the 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.
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