QC Analyst

$70,720 - $79,040/Yr

Astrix Technology - Indianapolis, IN

Full-time

Indianapolis, IN

About the position

The Quality Control Analyst position is a critical role within our client's laboratory, which specializes in the development of nuclear medicine. The organization is dedicated to delivering high-quality products that adhere to the highest standards of safety and efficacy. As a QC Analyst, you will be part of a dynamic team that is committed to innovation and excellence in the field of nuclear medicine. This role involves a variety of responsibilities, including performing analytical testing, maintaining compliance with regulatory standards, and contributing to quality assurance processes. You will be expected to work Monday through Friday from 9 AM to 5 PM, with a focus on ensuring that all laboratory activities are conducted safely and effectively. In this position, you will engage in testing and analysis using advanced laboratory techniques such as High-Performance Liquid Chromatography (HPLC). You will conduct thorough testing of raw materials, in-process samples, and finished products, ensuring that all results are accurately documented and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). Your role will also involve performing gamma spectroscopy and sterility testing, as well as maintaining detailed records of all testing activities. Collaboration is key in this role, as you will work closely with other members of the Quality Control team and various departments to ensure seamless operations and adherence to quality standards. You will also participate in continuous improvement initiatives aimed at enhancing testing processes and overall efficiency. Your contributions will be vital in identifying and investigating deviations or out-of-specification results, supporting root cause analysis, and implementing corrective actions as necessary.

Responsibilities

• Perform analytical testing using HPLC and other laboratory techniques.
• Conduct testing of raw materials, in-process samples, and finished products.
• Perform gamma spectroscopy and analyze results as needed.
• Execute sterility testing and ensure compliance with established procedures.
• Maintain accurate and detailed records of all testing and analysis activities in compliance with GMP, GLP, and GDP.
• Review and compile test data, and prepare comprehensive reports.
• Ensure that all laboratory activities are conducted in accordance with safety regulations and company policies.
• Assist in the development and validation of test methods and procedures.
• Identify and investigate deviations or out-of-specification results, and contribute to root cause analysis and corrective actions.
• Support internal and external audits by providing necessary documentation and information.
• Safely handle and dispose of radioactive materials according to established protocols.
• Utilize aseptic techniques to maintain the integrity of samples and prevent contamination.
• Work closely with other QC team members and departments to ensure seamless operations and adherence to quality standards.
• Participate in continuous improvement initiatives to enhance testing processes and efficiency.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Life Sciences, or a related field.
• Minimum of 2 years of experience in a QC laboratory setting.
• Proven experience with HPLC, GMP, GLP, and GDP is required.
• Preferred experience with radioactive materials, gamma spectroscopy, sterility testing, aseptic technique, and raw materials testing.
• Strong analytical skills and attention to detail.
• Proficiency in using laboratory equipment and software.
• Excellent documentation and organizational skills.
• Ability to work independently and as part of a team.
• Strong problem-solving skills and a proactive approach to identifying and addressing issues.