Weekend QA Associate — GMP/ISO Compliance

INCOG BioPharma Services; Fishers (IN); On-site; USD 55,000 - 85,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a QA Associate to help ensure site compliance with regulations and ISO standards. The role focuses on supporting quality systems and driving a culture of efficiency and attention to detail.

You will work with the Quality Manager, perform on-floor QA activities, review documentation, and participate in deviations investigations using root cause analysis. Weekend shifts (Fri-Sun) are required with potential flexibility.

Qualifications

• Bachelor’s degree in a science field required.
• Minimum 2 years in GMP manufacturing QA.
• Knowledge of GDP, CAPA, deviations, and non-conformance.
• Excellent written and verbal communication.
• Strong computer and data analysis skills.

Responsibilities

• Maintain QA presence on the manufacturing floor.
• Review and approve QA documentation.
• Lead investigations on deviations with root cause analysis.
• Support batch record reviews and material release.
• Balance production timelines with quality assurances.
• Assist with safety and compliance initiatives.

Skills

Quality Assurance

GMP Manufacturing

Documentation

Cross-functional Collaboration

Data Analysis Tools

Communication Skills

Problem Solving

Education

Bachelor’s Degree in Science

2+ years GMP/QA experience

Tools

Veeva

SCADA

BMS

CMMS

LIMS

JMP

Minitab

Excel

Word

Visio

Job description

INCOG BioPharma Services in Fishers, IN is seeking a QA Associate to help ensure site compliance with regulations and ISO standards. The role focuses on supporting quality systems and driving a culture of efficiency and attention to detail.

You will work with the Quality Manager, perform on-floor QA activities, review documentation, and participate in deviations investigations using root cause analysis. Weekend shifts (Fri-Sun) are required with potential flexibility.