QC Team Lead — cGMP Lab, HPLC/GC Method Dev

Garonit Pharma; Northern (KY); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company匹配

Paid time off and holidays

Job summary

Garonit Pharmaceutical, Inc. is seeking a QC Team Lead to manage and mentor the QC Laboratory, ensuring accurate testing, method development, and data review in full compliance with FDA, ICH, CFR, and USP standards.

The role involves supervising QC chemists, overseeing testing for manufacturing, release, and stability, and coordinating with QA, Manufacturing, and R&D to resolve quality issues promptly. Onsite in New Jersey with a competitive benefits package.

Qualifications

• Bachelor’s degree in Chemistry or a related scientific field.
• Minimum 2+ years in a supervisory or management role in a pharmaceutical QC lab.
• Strong experience with Empower 3, HPLC, GC, and wet chemistry.
• Deep understanding of cGMP, ICH, CFR, and USP testing requirements.

Responsibilities

• Supervise and lead a team of QC chemists and analysts, providing technical guidance and support.
• Oversee analytical testing activities for manufacturing, product release, and stability programs.
• Review and interpret HPLC, GC, and wet chemistry data in compliance with cGMP requirements.
• Author, review, and maintain SOPs, analytical methods, validation protocols, and related laboratory documentation.
• Manage analytical testing performed by external contract laboratories and review their results.

Skills

Leadership

Quality Assurance

Regulatory Knowledge

Education

Bachelor’s degree in Chemistry or related field

Tools

Empower 3

HPLC

GC

Wet chemistry

Job description

Garonit Pharmaceutical, Inc. is seeking a QC Team Lead to manage and mentor the QC Laboratory, ensuring accurate testing, method development, and data review in full compliance with FDA, ICH, CFR, and USP standards.

The role involves supervising QC chemists, overseeing testing for manufacturing, release, and stability, and coordinating with QA, Manufacturing, and R&D to resolve quality issues promptly. Onsite in New Jersey with a competitive benefits package.