Batch Records QA Specialist — Quality & Compliance

INCOG BioPharma; Fishers (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid vacation days

Paid holidays

401(k) plan with company match (up to

3.5%

Job summary

INCOG BioPharma is seeking a QA Specialist – Batch Review to oversee the lifecycle review and disposition of parenteral batch records across Formulation, Filling, Inspection, and Packaging. You will support client access, train QA staff, and help close deviations to ensure on-time batch release.

The role requires a Bachelor’s degree in a related science, 4+ years GMP experience, and 2+ years in aseptic environments, with strong communication and data-analysis skills for cross-functional

Qualifications

• Bachelor’s degree in a related science.
• 4+ years of GMP environment experience.
• 2+ years in aseptic processing in cleanroom/isolation environments.
• Excellent written and verbal communication skills.
• General computer skills with SCADA, data analysis software.

Responsibilities

• Full lifecycle review and disposition of parenteral Batch Records for Media Fills and Drug Product.
• Provide Client access and support in batch review and approval.
• Train QA Associates on surveillance oversight and batch review requirements.
• Drive timely completion of deviations to support on-time batch release.

Skills

QA & Batch Review

Root Cause Analysis

Data Analysis

Written & Verbal Communication

Education

Bachelor’s Degree in Chemistry/Biology/ Biochemistry

Tools

SCADA

LIMS

eDMS

JMP/Minitab/Excel (data analysis)

Job description

INCOG BioPharma is seeking a QA Specialist – Batch Review to oversee the lifecycle review and disposition of parenteral batch records across Formulation, Filling, Inspection, and Packaging. You will support client access, train QA staff, and help close deviations to ensure on-time batch release.

The role requires a Bachelor’s degree in a related science, 4+ years GMP experience, and 2+ years in aseptic environments, with strong communication and data-analysis skills for cross-functional