Lead QC Chemist — cGMP & HPLC/GC Expert (Onsite NJ)

Garonit Pharmaceutical; Flanders (NJ); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company**

Paid time off (PTO)

Paid holidays

Other company benefits

Job summary

Garonit Pharmaceutical, Inc. is seeking a QC Team Lead to manage the daily operations of the QC Laboratory in Flanders, NJ. You will lead testing, method development, and data review while ensuring cGMP compliance.

The role requires hands‑on technical expertise and strong leadership to supervise QC chemists, optimize workflows, and mentor staff. Onsite, with collaboration across QA, Manufacturing, and R&D, and a focus on data integrity and safety.

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.
• Oversee analytical testing 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 analytical results and documentation.
• Conduct, support, author, and review laboratory investigations, CAPAs, deviations, and change controls.
• Actively participate in internal audits, customer audits, and regulatory inspections.
• Manage and schedule laboratory workloads and resources to meet production and product‑release timelines.
• Ensure laboratory safety, data integrity, and compliance with FDA, ICH, and cGMP requirements.
• Collaborate cross‑functionally with Quality Assurance, Manufacturing, R&D, and other departments to resolve quality‑related issues promptly.
• Develop, train, and mentor QC staff through technical training, coaching, and performance development.
• Support continuous improvement initiatives to enhance laboratory compliance, efficiency, productivity, and overall quality.

Skills

Leadership

Training

Coaching

Problem-solving

Documentation

Communication

Attention to detail

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 the daily operations of the QC Laboratory in Flanders, NJ. You will lead testing, method development, and data review while ensuring cGMP compliance.

The role requires hands‑on technical expertise and strong leadership to supervise QC chemists, optimize workflows, and mentor staff. Onsite, with collaboration across QA, Manufacturing, and R&D, and a focus on data integrity and safety.