ADMA Biologics, Inc.
Job Summary
QA Specialist I – Manufacturing Oversight in Boca Raton, FL
ADMA Biologics is a biopharmaceutical company committed to producing superior products for people with immunodeficiency. We are looking for a QA Specialist I to perform manufacturing oversight to ensure compliance with policies and procedures.
Responsibilities
Perform real‑time manufacturing batch record review and review manufacturing documentation (logs, charts, etc.).
Review and approve event notifications.
Perform oversight and inspections of active production areas to resolve problems and ensure compliance with SOPs and policies.
Review and release plasma pools to manufacturing.
Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
Perform review and release of raw materials in LIMS/SAP.
Audit nitrogen receipt process.
Assist with quarantining and release of critical systems, equipment, and controlled environments.
Assist with other oversight activities as needed.
Coordinate and perform any additional activities or projects assigned by QA management.
Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers).
Rotate among QA specialists to provide 24/7 manufacturing oversight coverage. Required to work 12‑hour shifts.
Qualifications
1–3 years’ experience in the pharmaceutical or biotechnology industry.
Bachelor’s Degree preferred; experience can offset the degree requirement.
Understanding of Quality Systems (e.g., deviations, CAPAs, change controls, OOS).
Knowledge of cGMP and regulatory compliance (21 CFR Parts 11, 210, 211, 600).
Experience with LIMS and SAP preferred.
Ability to follow cGMP procedures with great attention to detail.
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 in the first year
Tuition assistance after the first year
Tri‑Rail shuttle to Boca Tri‑Rail station
Legal Reporting ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. To learn more about E‑Verify, please visit www.dhs.gov/E‑Verify.
ADMA Biologics is an Equal Opportunity Employer.
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ADMA Biologics is a biopharmaceutical company committed to producing superior products for people with immunodeficiency. We are looking for a QA Specialist I to perform manufacturing oversight to ensure compliance with policies and procedures.
Responsibilities
Perform real‑time manufacturing batch record review and review manufacturing documentation (logs, charts, etc.).
Review and approve event notifications.
Perform oversight and inspections of active production areas to resolve problems and ensure compliance with SOPs and policies.
Review and release plasma pools to manufacturing.
Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
Perform review and release of raw materials in LIMS/SAP.
Audit nitrogen receipt process.
Assist with quarantining and release of critical systems, equipment, and controlled environments.
Assist with other oversight activities as needed.
Coordinate and perform any additional activities or projects assigned by QA management.
Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers).
Rotate among QA specialists to provide 24/7 manufacturing oversight coverage. Required to work 12‑hour shifts.
Qualifications
1–3 years’ experience in the pharmaceutical or biotechnology industry.
Bachelor’s Degree preferred; experience can offset the degree requirement.
Understanding of Quality Systems (e.g., deviations, CAPAs, change controls, OOS).
Knowledge of cGMP and regulatory compliance (21 CFR Parts 11, 210, 211, 600).
Experience with LIMS and SAP preferred.
Ability to follow cGMP procedures with great attention to detail.
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 in the first year
Tuition assistance after the first year
Tri‑Rail shuttle to Boca Tri‑Rail station
Legal Reporting ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. To learn more about E‑Verify, please visit www.dhs.gov/E‑Verify.
ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr