QA Specialist Manufacturing Oversight
Company: ADMA Biologics
Location: Boca Raton
Posted on: June 23, 2022
- Perform Quality Assurance review and approval of Deviation
- 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
- 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
- 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
- Coordinate and perform any additional activities or projects
assigned by QA Management.
- Experience with LIMS and SAP preferred.
- - - Education Requirements: - - - - - -
- Bachelors 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
ADMA Biologics -is an Equal Opportunity Employer.
Keywords: ADMA Biologics, Boca Raton , QA Specialist Manufacturing Oversight, Other , Boca Raton, Florida
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