Quality Control Team Lead New Flanders, New Jersey

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

We’re looking for a QC Team Lead who’s both a hands-on technical expert and a strong leader. This role manages the daily operations of our QC Laboratory — leading testing, method development, and data review while ensuring full cGMP compliance.

Key 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.

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.
• Excellent problem-solving, documentation, and communication abilities.
• High attention to detail, strong work ethic, and commitment to quality.

The anticipated salary range for this position is $80,000–$110,000 per year. Actual compensation will be determined based on factors such as experience, qualifications, skills, and other job-related considerations. This position is also eligible for consideration for a discretionary year-end bonus, based on Company and individual performance. Any bonus is discretionary and is not guaranteed.Garonit Pharmaceutical offers eligible employees a benefits package that includes medical, dental, and vision insurance; a 401(k)-retirement plan with Company match; paid time off (PTO); paid holidays; and other benefits in accordance with applicable Company plans and policies.

About The Role

This is a full-time, onsite position based in our Quality Control laboratory in Flanders, New Jersey. The position involves routine use of analytical instrumentation and laboratory equipment and requires adherence to applicable safety, quality, and cGMP requirements.

Garonit Pharmaceutical, Inc. is an equal opportunity employer. We are committed to providing equal employment opportunities to all applicants and employees in accordance with applicable federal, state, and local laws.