Night-Shift QA Associate — GMP Compliance & Documentation

INCOG BioPharma; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a QA Associate to ensure site compliance with GMP regulations, ISO standards and GDP practices. You will review batch records, support deviations investigations, and promote a culture of quality and efficiency across manufacturing operations.

The role requires strong written and verbal communication, cross-functional collaboration, and the ability to manage multiple projects in a fast-paced environment, including occasional weekend coverage on third

Qualifications

• Bachelor’s degree in Science required (Chemistry, Biology, Biochemistry, Microbiology preferred).
• Minimum 2 years in GMP pharma quality roles or manufacturing.
• Knowledge of GDPs and regulatory quality systems (CAPA, deviations, non-conformance) preferred.

Responsibilities

• Maintain a Quality Assurance presence on the manufacturing floor and provide process confirmation.

Skills

Quality mindset

Interpersonal skills

Communication skills

Root cause analysis

Project management

Education

Bachelor’s Degree in Science

Tools

Veeva

SCADA

BMS

CMMS

LIMS

JMP

Minitab

Excel

Visio

Job description

INCOG BioPharma in Fishers, IN is seeking a QA Associate to ensure site compliance with GMP regulations, ISO standards and GDP practices. You will review batch records, support deviations investigations, and promote a culture of quality and efficiency across manufacturing operations.

The role requires strong written and verbal communication, cross-functional collaboration, and the ability to manage multiple projects in a fast-paced environment, including occasional weekend coverage on third