Quality Control Analyst

$54,080 - $62,400/Yr

Actalent - Vernon Hills, IL

Full-time - Entry Level

Vernon Hills, IL

11-50 employees

Administrative and Support Services

About the position

The Quality Control Analyst will be responsible for operating the materials management system, preparing mobile phases, samples, and standards for laboratory procedures, and ensuring proper waste disposal and record keeping. This role involves executing and optimizing Standard Operating Procedures (SOPs) in compliance with cGMP regulations, analyzing experimental outcomes, and collaborating with management on various tasks, including technology transfer. The position requires proficiency in analytical instruments and software, particularly UPLC and Empower, and entails performing routine analytical tests on pharmaceutical products.

Responsibilities

• Operate the materials management system integrating receiving, quarantine, release, inventory, and disposal mechanisms.
• Prepare mobile phase, samples, and standards for use in procedures, preventing waste or loss of materials.
• Maintain proper waste disposal handling and record keeping.
• Participate in the execution and optimization of Standard Operating Procedures (SOPs) for equipment and instrumentation per cGMPs.
• Correctly analyze and interpret the outcome of experiments.
• Prepare and assemble documentation such as entries into laboratory notebooks and maintain proper records per relevant SOPs and policies.
• Collaborate with supporting management for assigned tasks, including technology transfer.
• Learn regulations, legal requirements, policies, and procedures relevant to areas of responsibility.
• Apply knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed.
• Become proficient with UPLC, Empower, and various other analytical instruments and software packages.
• Perform routine analytical tests of excipients, APIs, finished products, compounded sterile preparations, and stability samples.
• Create and maintain clear and concise lab records and documentation.
• Ensure the timely execution of lab analysis and related documentation.
• Support daily analysis and stability study activities with significant supervision.

Requirements

• Bachelor's Degree in Chemistry or Biology with a Chemistry Minor.
• 1-2 years of experience with UPLC/HPLC.
• Experience with Microsoft Office (Word, Excel).
• Pharmaceutical/FDA exposure.
• Experience with cGMP.
• Proficiency with Empower software.

Benefits

• Flexible work environment
• Excellent training and growth opportunities