Quality Assurance Chemist

3 weeks ago


Westfield, Indiana, United States Isotopia USA Full time
Quality Control Chemist Job Description

Isotopia USA is a leading biotech company that manufactures key ingredients for pharmaceutical cancer drugs. We are seeking a highly motivated and detail-oriented Quality Control Chemist to join our dynamic team at our US headquarters in Indianapolis.

Key Responsibilities:

  • Perform routine testing of raw materials, in-process materials, and radiopharmaceutical products
  • Execute method validation protocols and generate reports
  • Execute stability protocols and generate reports
  • Assist with method development and implementation
  • Comply with cGMP requirements for recording of data
  • Perform routine inspections of laboratory notebooks and of the laboratory environment in accordance with written inspection procedures
  • Perform routine wipe and survey testing for radiation protection
  • Maintain inventory of materials required for analytical testing
  • Assist with analytical equipment IQ/OQ/PQ protocol execution
  • Coordinate with third-party equipment vendors to schedule routine equipment requalification
  • Assist with drafting analytical equipment risk assessments
  • Assist with trending of data and report drafting as needed
  • Assist with environmental monitoring program as needed
  • 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 routine test documents, method validation protocols/reports, and method development protocols/reports

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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