Specialist QA II Manufacturing Oversight

Specialist QA II Manufacturing Oversight

Position:
Specialist QA II Manufacturing Oversight

Location:

Boca Raton, FL

Company: ADMA Biologics

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.

• Possess and understand 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 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.).
• 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.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

• Exceptional organizational and communication skills required. Must have excellent writing and oral skills.
• Education:
  
  Bachelor’s Degree preferred but can be offset by experience.
• Experience:
  
  3‑5 years’ experience in pharmaceutical or biotechnology industry or other related industry.

• 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.
• ADMA Biologics is an Equal Opportunity Employer.

To learn more about E‑Verify, including your rights and responsibilities, please visit (Use the "Apply for this Job" box below)..