2nd-Shift QA Associate: GMP & Quality Investigator

INCOG BioPharma

Fishers (IN)

On-site

USD 60,000 - 90,000

Full time

14 days+

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Job summary

INCOG BioPharma, located in Fishers, IN, seeks a Quality Assurance Associate to uphold site compliance with regulations, ISO standards, and SOPs. You will support deviations investigations, review batch records, and ensure data integrity using systems like SCADA, LIMS, and CMMS.

The role emphasizes quality mindset, attention to detail, and timely delivery, with a focus on cross-functional collaboration. The position requires a Bachelor’s degree in science and at least two years in a GMP

Qualifications

Bachelor’s Degree required or equivalent; degree preferred in Science (Chemistry, Biology, Biochemistry, Microbiology).
Minimum 2 years of experience in QA within a GMP manufacturing environment.
Familiarity with deviations, Non-Conformance, CAPA, GDPs, and quality systems.
Strong written and verbal communication; ability to work cross-functionally and manage multiple projects.

Responsibilities

Maintain QA presence on the manufacturing floor and provide process confirmation.
Review and approve quality documentation (on-floor batch records, logbooks, procedures).
Lead or support investigations to resolve equipment and process deviations.
Assist with batch record reviews, material release, and data integrity tasks.
Balance production timelines with product quality assurances; quick decision-making for deviations.