BioSpace
Specialist QA II Manufacturing Oversight
ADMA Biologics is a biopharmaceutical company committed to creating superior products for patients at risk for infection. We are seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL.
Job Responsibilities
Perform manufacturing oversight activities to ensure compliance with policies and procedures.
Review real-time manufacturing batch records, logs, charts, and documentation.
Perform quality assurance review and approval of Deviation Reports and oversight of active production areas.
Review and release Plasma pools, raw materials in LIMS/SAP, and perform audits of nitrogen receipt process.
Assist with training of new employees and coordinate additional projects assigned by QA Management.
Write, review, and revise QA SOPs and provide feedback on documents from other departments.
Qualifications
Bachelor’s Degree preferred; 3-5 years’ experience in pharmaceutical or biotechnology industry.
Strong understanding of Quality Systems (CAPAs, OOSs), cGMP, and regulatory compliance 21 CFR Parts 11, 210, 211, 600.
Experience with LIMS and SAP preferred.
Benefits
401K plan with employer match and immediate vesting.
Medical, Vision, Life, and Dental Insurance.
Pet Insurance and Company Paid STD and LTD.
Company Paid Holidays and 3 Weeks’ Paid Time Off.
Tuition Assistance (after the first year).
Easily accessible to Tri-Rail Free shuttle to the Boca Tri-Rail station.
Equal Opportunity Employer ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
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Job Responsibilities
Perform manufacturing oversight activities to ensure compliance with policies and procedures.
Review real-time manufacturing batch records, logs, charts, and documentation.
Perform quality assurance review and approval of Deviation Reports and oversight of active production areas.
Review and release Plasma pools, raw materials in LIMS/SAP, and perform audits of nitrogen receipt process.
Assist with training of new employees and coordinate additional projects assigned by QA Management.
Write, review, and revise QA SOPs and provide feedback on documents from other departments.
Qualifications
Bachelor’s Degree preferred; 3-5 years’ experience in pharmaceutical or biotechnology industry.
Strong understanding of Quality Systems (CAPAs, OOSs), cGMP, and regulatory compliance 21 CFR Parts 11, 210, 211, 600.
Experience with LIMS and SAP preferred.
Benefits
401K plan with employer match and immediate vesting.
Medical, Vision, Life, and Dental Insurance.
Pet Insurance and Company Paid STD and LTD.
Company Paid Holidays and 3 Weeks’ Paid Time Off.
Tuition Assistance (after the first year).
Easily accessible to Tri-Rail Free shuttle to the Boca Tri-Rail station.
Equal Opportunity Employer ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr