QA Operations Associate

Goodwin-Biotechnolog; Plantation (FL); On-site; USD 65,000 - 85,000; Full time

Job summary

Goodwin-Biotechnolog is seeking a QA Operations Associate to provide hands-on, on-the-floor quality assurance during manufacturing, ensuring GMP compliance and real-time risk assessment.

The role requires 1+ year GMP experience, knowledge of aseptic manufacturing and data integrity, and the ability to make independent quality judgments on the production floor. On-site Florida plantation facility.

Qualifications

• Minimum high school diploma; associates or bachelor's 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 on the manufacturing floor and in classified areas.
• Perform GMP walkthroughs to assess aseptic practices and compliance.
• Act as primary QA contact during manufacturing activities.
• Make independent GMP decisions, escalate, or stop operations when needed.
• Support deviation investigations.
• Review and approve batch records, logbooks, and cleaning docs.
• Support media fills, line clearances, and room/equipment releases.
• Review SOPs, batch records, and specifications.
• Support audits, inspections and readiness activities.
• Coordinate archiving of manufacturing records with QA Docs Control.
• Assist in preparing batch Certificates of Compliance and Assurance.
• Provide QA support for electronic environmental systems and NetSuite.

Skills

GMP compliance

QA on-floor presence

Data integrity

Aseptic manufacturing

Education

High school diploma

Associate degree

Bachelor’s degree

Tools

NetSuite ERP

Electronic environmental system

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.