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 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.
• Carefully coordinate 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

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

Compliance Requirements (ES)

• 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
• 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

• Equal Opportunity Employer