Night-Shift Quality Assurance Associate (GMP)

INCOG BioPharma Services; Fishers (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

INCOG BioPharma Services is seeking a QA Associate to ensure site compliance with GMP regulations and ISO standards. The role involves reviewing batch records, supporting deviation investigations, and maintaining data integrity across SCADA, LIMS, and related systems.

You will work closely with QA and Manufacturing to uphold quality and timely product release. The position requires a Bachelor’s Degree in Science and at least 2 years of GMP QA experience.

Qualifications

• Bachelor’s Degree in Science (Chemistry, Biology, Biochemistry, Microbiology or equivalent).
• Minimum 2 years of QA experience in a GMP manufacturing environment or as an operator in pharmaceutical manufacturing.

Responsibilities

• Maintain QA presence and provide process confirmation on the manufacturing floor.
• Review and approve documentation for Quality approval (batch records, logbooks, work orders, procedures).
• Collaborate with Manufacturing/Operations to lead or support investigations of deviations.
• Support batch record reviews, material releases, and related QA tasks.
• Balance production timelines with product quality assurances.

Skills

Quality Assurance

GMP

Documentation

Communication

Education

Bachelor’s Degree in Science

Tools

SCADA

Veeva

BMS

CMMS

LIMS

JMP

Minitab

Job description

INCOG BioPharma Services is seeking a QA Associate to ensure site compliance with GMP regulations and ISO standards. The role involves reviewing batch records, supporting deviation investigations, and maintaining data integrity across SCADA, LIMS, and related systems.

You will work closely with QA and Manufacturing to uphold quality and timely product release. The position requires a Bachelor’s Degree in Science and at least 2 years of GMP QA experience.