Specialist QA II Manufacturing Oversight

About the role

The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Responsibilities

• Perform Quality Assurance review and approval of Deviation Reports.
• Perform oversight and inspections of active production areas to resolve problems and ensure compliance with SOPs and policies.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities.
• 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.

Requirements

• Exceptional organizational and communication skills.
• Excellent writing and oral skills.
• Bachelor’s Degree preferred but can be offset by experience.
• 3-5 years’ experience in pharmaceutical or biotechnology industry or other related industry.

Qualifications

• Understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
• Understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.

Compliance Requirements

• 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 Short-Term Disability (STD) and Long-Term Disability (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.