QA Specialist II-Manufacturing Oversight

Description

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 Performs 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

• 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 www.dhs.gov/E-Verify. 
 
ADMA Biologics is an Equal Opportunity Employer.