GMP Quality Control & Data Integrity Lead

Harba; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Harba is seeking a qualified candidate to conduct thorough technical reviews of analytical and microbiological testing data, ensuring compliance with GMP standards. The role involves leading laboratory investigations and acting as a Subject Matter Expert (SME) for QC database systems.

Ideal candidates will have a Bachelor’s degree in Chemistry or a related field, along with 5–7 years of experience in a GMP-regulated environment. The position offers a chance to mentor lab analysts and drive continuous improvement projects.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or Life Sciences.
• 5–7 years of experience in a GMP-regulated environment.

Responsibilities

• Conduct comprehensive technical reviews of testing data and ensure compliance with GMP standards.
• Lead laboratory investigations and identify root causes.
• Act as a Subject Matter Expert for electronic QC database systems.
• Mentor laboratory analysts on GMP fundamentals and practices.

Skills

GMP compliance

Analytical testing

Data integrity

Method validation

Technical documentation

Laboratory investigations

Mentorship

Education

Bachelor’s degree in Chemistry, Biology, or Life Sciences

Job description

Harba is seeking a qualified candidate to conduct thorough technical reviews of analytical and microbiological testing data, ensuring compliance with GMP standards. The role involves leading laboratory investigations and acting as a Subject Matter Expert (SME) for QC database systems.

Ideal candidates will have a Bachelor’s degree in Chemistry or a related field, along with 5–7 years of experience in a GMP-regulated environment. The position offers a chance to mentor lab analysts and drive continuous improvement projects.