Job Title: QC Chemist

Job Description

As a QC Chemist, you will be responsible for ensuring the integrity, accuracy, and compliance of analytical testing and quality systems. You will play a key role in maintaining GMP standards and supporting the release of high-quality pharmaceutical products.

Responsibilities

• Operate GC/HPLC instruments under GxP requirements with at least 1 year of hands-on experience.
• Perform analytical testing in accordance with method SOPs under GMP conditions.
• Inspect production and packaging activities; ensure completeness and accuracy of manufacturing records.
• Lead method validation efforts per USP and other applicable regulatory standards.
• Revise and maintain method SOPs to ensure compliance with current regulations.
• Coordinate calibration and maintenance of laboratory instruments and equipment.
• Manage vendor qualification programs and coordinate testing with external laboratories.
• Review laboratory results, notebooks, and related documentation for accuracy and compliance.
• Receive, inspect, and release or reject raw materials and packaging components; update inventory systems.
• Maintain and manage the stability program, including drafting protocols, reviewing results, and performing trend analysis.
• Control and maintain master labels and retain sample programs.
• Conduct environmental monitoring and maintain temperature and water system records.
• Perform regular sampling and sanitization of the water system.
• Manage laboratory standards, reagents, and chemicals; ensure timely disposal of expired materials.

Essential Skills

• Proficiency in operating GC/HPLC instruments under GxP/GMP conditions.
• Strong understanding of USP, ICH, and FDA guidelines.
• Experience with method validation and stability testing.
• Excellent documentation, organizational, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Additional Skills & Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum 1 year of experience operating GC/HPLC under GxP/GMP conditions.

Work Environment

The work environment involves running 5-10 samples a day using HPLC and GC, with the expectation to eventually manage 1-3 instruments simultaneously. The samples processed are liquid pharmaceutical products. The shift hours are Monday to Wednesday, 8 am to 4:30 pm with a 1-hour lunch break. The QC team consists of 11 members.