Specialist QA II Manufacturing Oversight

Position Summary

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.

Essential Functions (ES) and Responsibilities

• 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.
• Clock in and perform any additional activities or projects assigned by QA Management.

Job Responsibilities or Job Requirements

• Experience with LIMS and SAP preferred.

Competencies

• Experience Requirements: 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.
• Preferred Experience: Compliance Requirements (ES)

Experience Requirements

• Experience Requirements: 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

Education Requirements

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

Compliance Requirements (ES)

• The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and 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
• 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

• ADMA Biologics is an Equal Opportunity Employer.