QA Auditor I: GMP & In-Process Quality

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401k with employer match

Paid Time Off

Paid Holidays and Floating Holiday

Job summary

Aveva Drug Delivery Systems Inc. is seeking a Quality Assurance In-Process (QAIP) Auditor I to support Manufacturing, Packaging, R&D, and QC operations by performing line clearance, visual inspection of finished products, and sampling from the production line.

The role includes on-line batch record review, AQL planning, QA envelope documentation, and collaboration with Production to resolve quality issues while maintaining GMP compliance and adherence to Aveva SOPs.

Qualifications

• High School Diploma or equivalent; two years college preferred.
• Two to four years of related experience in pharmaceutical manufacturing.
• Experience working in GMP environments is a plus.

Responsibilities

• Ensure GMP compliance throughout the facility.
• Perform room and equipment line clearance for packaging processes.
• On-line batch record review for conformity to batch records and product specs.
• Prepare and execute AQL plans and QA Envelope documentation.
• Sample products for on-line inspection, stability, and reworks.
• Monitor product defects tracking and defect library; coordinate investigations.

Skills

Written communication

Verbal communication

MS Office

Interpersonal skills

Attention to detail

Multitasking

Education

High School Diploma or equivalent; two years college preferred

Tools

JD Edwards ERP

Job description

Aveva Drug Delivery Systems Inc. is seeking a Quality Assurance In-Process (QAIP) Auditor I to support Manufacturing, Packaging, R&D, and QC operations by performing line clearance, visual inspection of finished products, and sampling from the production line.

The role includes on-line batch record review, AQL planning, QA envelope documentation, and collaboration with Production to resolve quality issues while maintaining GMP compliance and adherence to Aveva SOPs.