GMP QA Associate - Weekend Shift

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

Job summary

INCOG BioPharma, based in Fishers, IN, seeks a QA Associate to ensure site compliance with GMP regulations and ISO standards. You will champion quality mindset, support in identifying operational gaps, and collaborate across functions to maintain data integrity and product quality.

The role requires the ability to manage multiple projects, provide clear written and verbal communication, and participate in weekend operations with flexible shifts.

Qualifications

• Bachelor’s degree in Science or equivalent required.
• Minimum of 2 years in a GMP manufacturing environment or as an operator in pharma manufacturing.
• Knowledge of GDPs and good documentation practices.
• Excellent written and verbal communication skills.
• Strong computer skills with SCADA, reporting and data analysis tools.

Responsibilities

• Maintain a Quality Assurance presence on the manufacturing floor and provide process confirmation.
• Review and approve documentation for quality approval, including batch records, logbooks, and procedures.
• Collaborate with Manufacturing/Operations to lead or support investigations of deviations and implement corrective actions.
• Support batch record reviews and material release as needed.
• Balance production timelines with product quality assurances and exercise rapid decision-making on deviations.
• Leverage root cause analysis tools and risk assessment to mitigate issues and improve processes.

Skills

GMP Experience

Deviation Investigation

Root Cause Analysis

Documentation Control

Data Integrity

Cross-Functional

Education

Bachelor’s Degree in Science

Tools

SCADA

LIMS

Veeva

CMMS

BMS

Job description

INCOG BioPharma, based in Fishers, IN, seeks a QA Associate to ensure site compliance with GMP regulations and ISO standards. You will champion quality mindset, support in identifying operational gaps, and collaborate across functions to maintain data integrity and product quality.

The role requires the ability to manage multiple projects, provide clear written and verbal communication, and participate in weekend operations with flexible shifts.