What are the responsibilities and job description for the QC Analyst III position at Evergreen Theragnostics?
QC Analyst 3
Job Title: Quality Control Laboratory Analyst 3 – Radiopharmaceuticals
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company beginning operations in Springfield, NJ. The state-of-the-art facility will provide contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. Evergreen is a small team, where all team members support each other in a variety of activities.
Job Description:
We are looking for an experienced and proactive Quality Control Laboratory Analyst 3 to join our team. In this role, the candidate will participate in critical quality control processes for our radiopharmaceutical products, ensuring all operations comply with stringent industry standards and regulatory guidelines. The ideal candidate will have significant experience in pharmaceutical or radiopharmaceutical environments, a strong background in analytical techniques, and the ability to troubleshoot laboratory equipment.
Key Responsibilities:
- Lead quality control testing and analysis of radiopharmaceutical products, ensuring adherence to both internal specifications and regulatory standards.
- Maintain a clean, safe, and organized lab environment, adhering to all safety and pharmaceutical regulations, including radiation safety protocols.
- Perform daily lab tasks, including solution preparation, drug product analysis, and documentation of all testing.
- Independently operate, maintain, and troubleshoot laboratory equipment such as GC (Gas Chromatography), TLC (Thin Layer Chromatography), and HPLC (High-Performance Liquid Chromatography).
- Perform routine and complex analysis, troubleshooting issues with laboratory instrumentation as needed to ensure accurate results.
- Ability to be the primary QC operator on all projects, taking ownership of testing and analytical activities across multiple initiatives.
- Mentor and train new team members on laboratory techniques, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and company-specific procedures.
- Ensure proper documentation practices, maintaining a high level of accuracy in lab notebooks.
- Collaborate with cross-functional teams to resolve quality issues and contribute to continuous improvement initiatives.
- Assist with management of QC materials, including ordering supplies, tracking inventory, and ensuring availability of materials necessary for testing.
Qualifications:
- 5 years of experience in the pharmaceutical, life sciences, or radiopharmaceutical industry
- Bachelor's degree in a scientific field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences), or equivalent relevant work experience.
- Extensive hands-on experience with laboratory techniques, including GC, TLC, and HPLC, as well as troubleshooting of each.
- Proven ability to be the primary QC analyst on complex projects, managing multiple responsibilities and ensuring quality deliverables.
- Strong experience in inventory management, including the ordering and monitoring of QC supplies and reagents.
- In-depth knowledge of GMP, GDP, and regulatory documentation standards.
- Strong troubleshooting and problem-solving skills related to laboratory equipment and procedures.
- Ability to mentor and train new team members on both technical skills and regulatory requirements, with a focus on GMP/GDP.
- Capable of maintaining detailed and accurate documentation in lab notebooks, with minimal QA corrections.
Working Environment:
- Laboratory setting with exposure to radiation and other chemical hazards.
- Required to wear personal protective equipment (PPE) such as lab coats, gloves, and safety goggles.
- Fast-paced laboratory setting, requiring multitasking and prioritizing several projects.
- Occasional lifting and movement of materials; commitment to maintaining a safe and organized working environment.
