BioSpace
QA Specialist II, Manufacturing Oversight - Night Shift
BioSpace, Boca Raton, Florida, us, 33481
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
www.dhs.gov/E-Verify . We are an Equal Opportunity Employer.
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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
www.dhs.gov/E-Verify . We are an Equal Opportunity Employer.
#J-18808-Ljbffr