What are the responsibilities and job description for the Specialist QA I - Manufacturing Oversight - Night position at ADMA BIOMANUFACTURING LLC?
Job Details
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 I - Manufacturing Oversight - Night in Boca Raton, FL!
The QA Specialist I - Manufacturing Oversight - Night 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 an understanding of 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 Event notifications.
- Possess and understanding of 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.)
- Perform review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.
- 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 is preferred.
Education Requirements: Bachelor’s Degree required.
Experience Requirements: 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred
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 is an Equal Opportunity Employer.
