On-the-Floor QA Ops Lead (GMP/Aseptic)

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

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.