QA Specialist II-Manufacturing Oversight
Location: Boca Raton
Posted on: June 23, 2025
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Job Description:
Job DetailsLevel ExperiencedJob Location ADMA Biologics FL -
Boca Raton, FLPosition Type Full TimeEducation Level 4 Year
DegreeTravel Percentage NoneJob Shift DayJob Category
PharmaceuticalDescription ADMA Biologics is a biopharmaceutical
company relentlessly committed to creating superior products for
immunodeficient patients at risk for infection. It is our devotion
to this underserved population that fuels us and our hands-on
approach to production and development that sets us apart. If you
are looking for a dynamic, innovative, growing company in the
biopharmaceutical industry that is committed to excellence and
integrity, then consider ADMA Biologics. We currently have an
exciting opportunity available for a QA Specialist II-Manufacturing
Oversight in Boca Raton, FL! The QA Specialist II - Manufacturing
Oversight will perform manufacturing oversight activities to ensure
compliance with policies and procedures. Oversight activities
include, but are not limited to, real-time manufacturing batch
record review, review of manufacturing documentation (logs, charts,
etc.), and resolution of issues on the manufacturing floor.
Qualifications ESSENTIALS OF THE JOB: Possess and understanding of
processes such as Quality Systems (e.g., Deviations, Corrective and
Preventive Action reports {CAPAs}, Change Controls, and Out of
Specifications {OOSs}). Perform Quality Assurance review and
approval of Deviation Reports. Possess an understanding cGMP and
regulatory compliance as defined in government regulations such as
21 CFR Parts 11, 210, 211, and 600. Perform oversight and
inspections of active production areas to resolve problems and to
ensure compliance with SOPs and policies. Perform general oversight
of Buildings 1 and 2 (including cold rooms/freezers) and their
associated activities, as required. Review and release of Plasma
pools to manufacturing. Review all manufacturing support
documentation (logbooks, log sheets, charts, etc.) Review and
release of raw materials in LIMS/SAP. Perform audits of Nitrogen
receipt process. Perform notification and disposition of associated
Lookback units. Assist with quarantining and release of critical
systems, equipment, and controlled environments.\ Write, review,
and revise QA SOPs. Review SOPs and documents from other
departments and provide feedback as necessary. Work with other
departments to assess if Deviations, CAPAs, and Change Controls are
required. Assist with training of new employees. Rotation amongst
QA Specialists to provide 24/7 manufacturing oversight coverage.
Required to work 12 hour shifts (07:00 AM to 07:00 PM or 07:00 PM
to 07:00 AM). Must be available to support coverage on either
shift. Assist in other oversight activities, as needed Coordinate
and perform any additional activities or projects assigned by QA
Management. Experience with LIMS and SAP preferred. EDUCATION
REQUIREMENTS: Bachelor's Degree preferred but can be offset by
experience. EXPERIENCE REQUIREMENTS: 3-5 years' experience in
pharmaceutical or biotechnology industry or other related industry.
In addition to competitive compensation, we offer a comprehensive
benefits package including: 401K 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) Easily accessible to Tri-Rail Company paid 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, Inc. uses
E-Verify to confirm the employment eligibility of all newly hired
employees. ADMA Biologics is an Equal Opportunity Employer.
Keywords: , Coral Gables , QA Specialist II-Manufacturing Oversight, Science, Research & Development , Boca Raton, Florida
