Senior QC Compliance Lead — GMP & Data Integrity

INCOG BioPharma Services; Fishers (IN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Paid vacation days

11 observed holidays

401(k) plan with company match

Health & wellness plans

FSA and HSA programs

Dental & vision care

Job summary

INCOG BioPharma Services is seeking a Senior Quality Control Compliance Specialist with extensive analytical and microbiological testing experience. The role supports finished products, raw materials, and stability samples, and leads continuous improvement projects.

The candidate will review data for integrity, generate certificates of analysis, and drive investigations and CAPAs. Collaboration with clients and training of analysts are part of the responsibilities.

Qualifications

• Bachelor’s degree in a chemistry, biology, or related science.
• 8+ years of experience in lab or quality roles.
• Experience with analytical and/or microbiology testing and GMPs.

Responsibilities

• Perform in-depth technical data review of analytical and microbiological testing with emphasis on data integrity.
• Generate QC data summary documents such as certificates of analysis and stability reports.
• Lead investigations, deviations, and change controls to completion and propose CAPAs.
• Provide SME support for electronic QC data systems (OpenLab).
• Draft specifications, protocols, SOPs, and revise methods and SOPs.

Skills

Analytical testing

Microbiology testing

Data review

GMP compliance

Root cause analysis

CAPA management

OpenLab expertise

Education

Bachelor’s degree in Chemistry, Biology, or related sciences

Tools

OpenLab

Electronic QC databases

Job description

INCOG BioPharma Services is seeking a Senior Quality Control Compliance Specialist with extensive analytical and microbiological testing experience. The role supports finished products, raw materials, and stability samples, and leads continuous improvement projects.

The candidate will review data for integrity, generate certificates of analysis, and drive investigations and CAPAs. Collaboration with clients and training of analysts are part of the responsibilities.