Overview
QA Specialist II, Manufacturing Oversight – Night Shift Jobs in Boca Raton, Florida, USA at BioSpace
Job Details
Job Location:
ADMA Biologics, Boca Raton, FL
Position Type:
Full Time
Job Shift: Nights
Job Category:
Pharmaceutical
Description
ADMA Biologics is a biopharmaceutical company committed to creating products for immunodeficient patients at risk for infection. We focus on production and development to serve this underserved population. If you seek a dynamic, innovative, growing company in the biopharmaceutical industry dedicated to excellence and integrity, consider joining ADMA Biologics. We currently have an exciting opportunity for a QA Specialist II – Manufacturing Oversight in Boca Raton, FL.
The QA Specialist II – Manufacturing Oversight will perform activities to ensure manufacturing compliance, including batch record reviews, documentation reviews, and issue resolution on the manufacturing floor.
Qualifications
Essentials of the Job:
Understanding of Quality Systems (Deviations, CAPAs, Change Controls, OOSs)
Review and approve Deviation Reports
Knowledge of cGMP and regulations such as 21 CFR Parts 11, 210, 211, 600
Oversee active production areas, ensuring SOP and policy compliance
Monitor Buildings 1 and 2, including cold rooms and freezers
Review and release Plasma pools and manufacturing support documentation
Review and approve raw materials in LIMS/SAP
Audit Nitrogen receipt process
Manage Lookback units’ notification and disposition
Assist with quarantine and release of systems and environments
Develop and update QA SOPs
Review SOPs from other departments and provide feedback
Collaborate on Deviations, CAPAs, and Change Controls assessments
Assist in training new employees
Provide 24/7 manufacturing oversight, working 12-hour shifts, and support other activities as needed
Coordinate additional projects assigned by QA Management
Experience with LIMS and SAP is preferred
Education
& Experience
Bachelor’s Degree preferred; experience may offset education requirements
3-5 years of experience in pharmaceutical, biotech, or related industries
Benefits
We offer a comprehensive benefits package, including:
401K with employer match and immediate vesting
Medical, Vision, Life, and Dental Insurance
Pet Insurance
Company paid STD and LTD
Paid Holidays
3 Weeks Paid Time Off (first year)
Tuition Assistance (after first year)
Easy access via Tri-Rail and shuttle service to Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm employment eligibility. For more information, visit (Use the “Apply for this Job” box below). We are an Equal Opportunity Employer.
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Title: QA Specialist II, Manufacturing Oversight – Night Shift
Company: BioSpace
Location: Boca Raton, Florida, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
