QC Analyst

Asahi Kasei • The Woodlands, TX

5d • $65,000 - $80,000 • Onsite

About The Position

We are seeking a full time direct hire QC Analyst to report to the QC Manager. You will be responsible for supporting analytical testing activities related to method transfer, verification, and qualification. The QC Analyst ensures all work is executed in accordance with established procedures, protocols, and regulatory requirements. This role requires close collaboration with the Lead QC Specialist, Manufacturing teams, and scientists within the Analytical Development group. Additionally, the QC Analyst will work cross-functionally across the site and interface with Bionova clients to ensure that laboratory results are accurate, reliable, and delivered in a timely manner.

Requirements

• Bachelor of Science degree or equivalent in a scientific field (chemistry, biology, etc.)
• 1-3 years of GMP Quality Control Laboratory experience including instrument qualification, testing, method transfer, etc.
• Hands-on experience with molecular biology or analytical techniques (e.g., UV/Vis, gel electrophoresis, endotoxin testing, PCR,)
• Understanding of cGMP regulations and quality standards
• Proficiency in data analysis, statistical methods, and scientific writing
• Excellent communication and collaboration skills to work effectively with cross-functional teams

Nice To Haves

• Experience with UPLC and ELISA is preferred

Responsibilities

• Support the team in the transfer of analytical methods, ensuring accuracy, compliance with regulatory standards, and smooth transition of testing procedures.
• Executing method transfer protocols, including method comparison studies, data analysis, and documentation to verify the accuracy and precision of analytical methods in the new laboratory.
• Maintain complete, accurate, and compliant records in accordance with GMP, GDP, and regulatory guidelines.
• Understanding of analytical techniques relevant to the release of plasmid DNA (e.g., HPLC, PCR, ELISA, Agarose Gel Electrophoresis), regulatory requirements (cGMP), and quality standards.
• Working closely with development scientists, manufacturing personnel, and quality assurance teams to facilitate seamless method transfer process.
• Assist in drafting and reviewing test methods, protocols, SOPs, and data reports.
• Maintain laboratory inventory, reagents, and consumables to support uninterrupted testing operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level