Quality Assurance Specialist
4 weeks ago
At Isotopia USA, we are seeking a highly skilled Quality Control Chemist to join our team. As a key member of our quality control department, you will play a crucial role in ensuring the safe and efficient production of our radiopharmaceutical products.
Responsibilities:
- Perform routine testing of raw materials, in-process materials, and radiopharmaceutical products to ensure compliance with cGMP requirements.
- Execute method validation protocols and generate reports to ensure the accuracy and reliability of our testing methods.
- Assist with method development and implementation to improve our testing capabilities.
- Comply with cGMP requirements for recording of data and maintain accurate and detailed laboratory notebooks.
- Perform routine inspections of the laboratory environment to ensure compliance with written inspection procedures.
- Perform routine wipe and survey testing for radiation protection to ensure a safe working environment.
- Maintain inventory of materials required for analytical testing and coordinate with production personnel to ensure timely testing and release of intermediate materials and final product.
- Coordinate with third-party equipment vendors to schedule routine equipment requalification and assist with drafting analytical equipment risk assessments.
- Assist with trending of data and report drafting as needed and coordinate with production personnel to ensure timely testing and release of intermediate materials and final product.
- Coordinate with production personnel to ensure timely testing and release of intermediate materials and final product and assist with environmental monitoring program as needed.
Requirements:
- Bachelor's degree in Chemistry is strongly preferred.
- Previous experience with compendial USP test methods, ICP-MS / ICP-OES, radio-TLC, and/or direct inoculation sterility testing is strongly preferred.
- Previous experience in pharmaceutical / radiopharmaceutical quality control is preferred.
- Strong understanding of cGMP requirements and radiation safety practices is preferred.
- Detail-oriented mindset with excellent organizational and record-keeping skills.
- Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
- Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
- Flexibility to work in shifts and handle time-sensitive processes.
- Strong commitment to safety, ethical conduct, and compliance with regulations.
- Physical ability to stand for extended periods, lift moderately heavy objects up to 50 pounds, and to handle frequent stooping and crouching, and wear appropriate PPE.
- Manual dexterity for manipulating small items.
Benefits:
- 401K Retirement Program with 3% of Salary Company Contribution.
- Individual and Dependent Health Insurance.
- Dental Insurance.
- Vision Insurance.
- Life Insurance.
- Short-term Disability Insurance.
- Long-term Disability Insurance.
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