Specialist QA I Manufacturing Oversight

Essential Functions (ES) And Responsibilities

• 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.
• 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.
• Audit of Nitrogen receipt process.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Assist in other oversight activities, as needed.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers).
• 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.

Experience Requirements

• 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred.

Education Requirements

• Bachelor's Degree preferred but can be offset by experience.

Preferred Experience

• Experience with LIMS and SAP is preferred.

Compliance Requirements (ES)

• The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities.
• Completion of required compliance training.
• Accurate documentation of sales interactions.
• Adherence to data privacy regulations.
• Proactive participation in compliance reviews.
• Prompt reporting of any potential issues.
• Ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting.
• Medical, Vision, Life and Dental Insurance.
• Pet Insurance.
• Company paid STD and LTD.
• 3 Weeks’ Paid Time Off (within the first year).
• Tuition Assistance (after the first year).

Additional Information

• 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.