Qa specialist serp_jobs.h1.location_city

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 :

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 :

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.