QA Operations Associate

GBI Bio; Plantation (FL); On-site; USD 60,000 - 80,000; Full time

Job summary

GBI Bio is seeking a QA Operations Associate to provide hands-on quality assurance on the manufacturing floor in a cGMP environment. The role requires independent judgment to ensure GMP compliance and real-time oversight of batch records, deviations, and room clearances.

You will collaborate with production teams to investigate issues, escalate quality risks, and support audits and inspections. A high school diploma is required, with preferred associate or bachelor’s degree.

Qualifications

• High school diploma minimum; Associate or Bachelor’s degree preferred.
• Strong knowledge of cGMP, aseptic manufacturing, and data integrity.
• 1 year+ GMP experience; independent floor oversight; support investigations.

Responsibilities

• Provide real-time QA presence and oversight for manufacturing operations on the floor.
• Perform GMP walkthroughs to assess compliance and aseptic practices.
• Act as the primary QA point-of-contact during manufacturing activities.
• Exercise independent GMP decision-making, including escalation and stopping operations when required.
• Support deviation investigations.
• Review and approve batch records, logbooks, and cleaning documentation as needed.
• Support media fills, line clearances, and room/equipment release.
• Review SOPs, batch records, and specifications.
• Support audits, inspections, and inspection readiness.
• Coordinate archiving of executed manufacturing records with QA Documentation Control.
• Assist in preparing batch Certificates of Compliance and Certificate of Assurance.
• Provide QA support for electronic environmental and ERP systems.

Skills

cGMP knowledge

Aseptic manufacturing

Data integrity

Education

Associate or Bachelor’s degree preferred

Job description

Description

Scope of Function: The QA Operations Associate is a hands-on, on-the-floor Quality Assurance professional responsible for ensuring GMP compliance during manufacturing operations while exercising independent quality judgment. The role provides real-time QA oversight and acts as a QA representative on the manufacturing floor, with responsibility for assisting in investigations, and escalation of quality risks.

Specific Duties

• Provide real-time QA presence and oversight for manufacturing operations in classified areas.
• Perform routine and ad hoc GMP walkthroughs to assess compliance and aseptic practices.
• Act as the primary QA point-of-contact during manufacturing activities.
• Exercise independent GMP decision-making, including escalation and stopping operations when required.
• support deviation investigations.
• Real-time review and approval of executed batch records, logbooks, and cleaning documentation.
• Support media fills, line clearances, and room/equipment release.
• Review, SOPs, batch records, and specifications.
• Support audits, inspections, and inspection readiness.
• Coordinates the archiving of executed manufacturing records with QA Documentation Control.
• Supports preparation of batch Certificate of Compliance and Certificate of Assurance, as applicable.
• Provide QA support for the electronic environmental system and the NetSuite enterprise system.

This job description summarizes the primary responsibilities of the role and does not represent a complete list of all duties. Duties and responsibilities may be modified, expanded, or reassigned at any time based on business needs.

Requirements

Education & Qualifications:

• High school diploma minimum; Associate or Bachelor’s degree preferred.
• Strong knowledge of cGMP, aseptic manufacturing, and data integrity.
• 1 year+ GMP experience; independent floor oversight; support investigations.