QA In-Process Lead – 503B Sterile Manufacturing

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 65,000 - 95,000; Full time

Job summary

Aveva Drug Delivery Systems in Tamarac, FL is strengthening its Quality Operations by adding dedicated QA In-Process (QAIP) personnel to support upcoming 503B operations. This expansion will heighten quality oversight to ensure cGMP compliance and uninterrupted sterile manufacturing.

The role focuses on real-time QA oversight, room release, in-process inspections, logbook reviews, and deviation support across production campaigns, ensuring product quality and regulatory adherence.

Qualifications

• Strong knowledge of cGMP regulations and pharmaceutical quality systems.
• Experience in manufacturing processes, aseptic processing, and documentation.
• Attention to detail with a commitment to accuracy and data integrity.
• Ability to manage multiple assignments in a dynamic, fast-paced environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Strong interpersonal and collaboration skills across departments.

Responsibilities

• Provide dedicated QAIP personnel support for 503B operations.
• Oversee room release, in-process inspections, and logbook reviews.
• Verify entries within in-process batch records and deviations.
• Ensure cGMP compliance and timely documentation of activities.
• Coordinate with Manufacturing during production campaigns and quality events.

Skills

cGMP regulations

pharmaceutical quality systems

aseptic processing

documentation

data integrity

multi-tasking

Microsoft Office

Education

B.A./B.S. degree

Job description

Aveva Drug Delivery Systems in Tamarac, FL is strengthening its Quality Operations by adding dedicated QA In-Process (QAIP) personnel to support upcoming 503B operations. This expansion will heighten quality oversight to ensure cGMP compliance and uninterrupted sterile manufacturing.

The role focuses on real-time QA oversight, room release, in-process inspections, logbook reviews, and deviation support across production campaigns, ensuring product quality and regulatory adherence.