Lead QC Chemists: cGMP Lab, Method Dev & Compliance

Garonit Pharmaceutical; Mount Olive (IL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

PTO

Paid Holidays

Job summary

Garonit Pharmaceutical is seeking a Quality Control Team Lead to manage the QC Laboratory, lead testing, method development, and data review while ensuring cGMP compliance. The role involves supervising QC chemists, overseeing analyses for manufacturing and release, and maintaining SOPs and validation protocols.

The ideal candidate has a Chemistry background, 2+ years in a supervisory role in pharma QC, and hands‑on expertise with Empower 3, HPLC, GC, and wet chemistry.

Qualifications

• Bachelor’s degree in Chemistry or related field.
• 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.
• Experience in method development, validation, and stability testing.
• Proven leadership, training, and coaching skills.
• Excellent problem‑solving, documentation, and communication abilities.
• High attention to detail, strong work ethic, and commitment to quality.

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 docs.
• Manage analytical testing by external contract laboratories and review their results.
• Conduct, support, author, and review laboratory investigations, CAPAs, deviations, and change controls.
• Participate in internal audits, customer audits, and regulatory inspections.
• Schedule laboratory workloads and resources to meet production and release timelines.
• Ensure laboratory safety, data integrity, and compliance with FDA, ICH, and cGMP.
• Collaborate cross‑functionally to resolve quality‑related issues promptly.
• Develop, train, and mentor QC staff through technical training and coaching.
• Support continuous improvement initiatives to enhance compliance, efficiency, productivity, and quality.

Skills

Supervision

Leadership

Training

Coaching

Data review

Documentation

Communication

Attention to detail

Education

Bachelor's degree in Chemistry

Tools

Empower 3

HPLC

GC

Wet chemistry

Job description

Garonit Pharmaceutical is seeking a Quality Control Team Lead to manage the QC Laboratory, lead testing, method development, and data review while ensuring cGMP compliance. The role involves supervising QC chemists, overseeing analyses for manufacturing and release, and maintaining SOPs and validation protocols.

The ideal candidate has a Chemistry background, 2+ years in a supervisory role in pharma QC, and hands‑on expertise with Empower 3, HPLC, GC, and wet chemistry.