Quality Control Team Lead: Pharma Testing & GMP

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Paid holidays

Job summary

Garonit Pharmaceutical is seeking a QC Team Lead to manage daily QC Lab operations, lead testing, and drive method development while ensuring full cGMP compliance. You will supervise QC chemists, review data, and maintain documentation in a fast-paced pharmaceutical environment.

The role requires hands-on technical expertise with Empower 3, HPLC, GC, and wet chemistry, plus leadership and training capabilities to mentor staff and support continuous improvement in quality and efficiency.

Qualifications

• Bachelor’s degree in Chemistry or a related scientific 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.

Responsibilities

• Supervise and lead a team of QC chemists and analysts, providing technical guidance and support.
• Oversee all 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 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

Supervisory experience

Leadership

Problem-solving

Documentation

Communication

Education

Bachelor’s degree in Chemistry or related field

Tools

Empower 3

HPLC

GC

Wet chemistry

Job description

Garonit Pharmaceutical is seeking a QC Team Lead to manage daily QC Lab operations, lead testing, and drive method development while ensuring full cGMP compliance. You will supervise QC chemists, review data, and maintain documentation in a fast-paced pharmaceutical environment.

The role requires hands-on technical expertise with Empower 3, HPLC, GC, and wet chemistry, plus leadership and training capabilities to mentor staff and support continuous improvement in quality and efficiency.