Company: ADMA Biologics, Inc.
Location: Boca Raton
Posted on: November 17, 2023
Job Location: ADMA Biologics - Boca Raton, FL
Position Type: Full Time
Education Level: 4 Year Degree
Salary Range: Undisclosed
Job Category: QA - Quality Control
DescriptionADMA Biologicsis 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
thebiopharmaceutical industry that is committed toexcellence
andintegrity, then consider ADMA Biologics. We currently have an
exciting opportunity available for a Quality Assurance Supervisor
in Boca Raton, FL!
The QA Supervisor oversees manufacturing operations to ensure
compliance with cGMPs, GDPs, exception reporting and continuous
improvement. Ensures daily MQA observations and other self-audit
observations are properly documented, communicated, trended, and
corrected appropriately to ensure continuous compliance with cGMPs,
corporate policies, standards, and procedures.Qualifications
Ensure cGMP and regulatory compliance as defined in government
regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as
compliance with corporate policies, standards, and procedures.
Interact with Manufacturing (Fractionation/Purification/Fill
Finish), Quality Control, Facilities/Engineering and other
production support units to develop and implement corrective
actions and process improvements.
Maintain a system for documenting observations daily MQA
walkthroughs and other self-audit observations.
Ensure observations are properly documented, communicated to
appropriate responsible departments, and corrective actions are
Conduct trending of observations from daily quality audits, ensure
appropriate corrective actions are initiated as adverse trends are
identified, and communicate trending results to management.
Perform review of GMP documents (e.g. batch production records,
batch testing records, etc.) to ensure compliance with GDPs, data
integrity corporate policies, standards, and procedures.
Establish and maintain processes for real-time data review in
Work with production personnel and other departments to resolve
documentation and compliance issues.
Coach, mentor, and develop staff, including overseeing new-employee
Organize and present data/information on assigned projects to
Author and revise SOP, Work Instructions, Forms, as needed.
Coordinate and perform any additional activities or projects
assigned by Quality Management.
Ensure timely escalation to senior management of any quality and
compliance matters and/or deviations from the approved processes,
policies/standards/procedures, discovered during the oversight of
manufacturing operations and audits of other areas on site.
Bachelor's degree preferred but can be offset by experience.
Three to five 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
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
Free 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
ADMA Biologics is an Equal Opportunity Employer.
Keywords: ADMA Biologics, Inc., Boca Raton , QA Supervisor, Other , Boca Raton, Florida
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