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Quality Assurance Specialist

2 months ago

Westfield, Indiana, United States Isotopia USA Full time
About the Role

Isotopia USA, a leading biotechnology company, is seeking a highly motivated and detail-oriented Quality Control Chemist to join our dynamic team. As a key member of our quality assurance team, you will play a crucial role in ensuring the safe and efficient production of our products.

Responsibilities
  • Perform routine testing of raw materials, in-process materials, and radiopharmaceutical products to ensure compliance with regulatory requirements.
  • Execute method validation protocols and generate reports to ensure the accuracy and reliability of our testing methods.
  • Execute stability protocols and generate reports to ensure the stability of our products over time.
  • Assist with method development and implementation to improve our testing capabilities.
  • Comply with current Good Manufacturing Practices (cGMP) requirements for recording of data and maintaining accurate records.
  • Perform routine inspections of laboratory notebooks in accordance with written inspection procedures to ensure compliance with regulatory requirements.
  • Perform routine wipe and survey testing for radiation protection to ensure a safe working environment.
  • Maintain inventory of materials required for analytical testing to ensure timely and efficient testing.
  • Assist with analytical equipment IQ/OQ/PQ protocol execution to ensure the accuracy and reliability of our testing equipment.
  • Coordinate with third-party equipment vendors to schedule routine equipment requalification to ensure compliance with regulatory requirements.
  • Assist with drafting analytical equipment risk assessments to identify potential risks and implement controls.
  • Assist with trending of data and report drafting as needed to provide insights and recommendations for process improvements.
  • Assist with environmental monitoring program as needed to ensure compliance with regulatory requirements.
  • Coordinate with production personnel to ensure timely testing and release of intermediate materials and final product.
  • Coordinate sampling plans and shipment of samples to third-party labs for any necessary third-party testing.
  • Assist with technical review of test documents and method development validation protocols and reports to ensure accuracy and reliability.
Requirements
  • Bachelor's degree in Chemistry is strongly preferred.
  • Previous experience with compendial USP test methods, ICP-MS / ICP-OES, and radio-TLC 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, while wearing appropriate PPE.
  • Manual dexterity for manipulating small items.