Quality Assurance Specialist

2 weeks ago


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

Isotopia USA is a leading biotech company dedicated to manufacturing key ingredients for pharmaceutical cancer drugs. Our US headquarters in Indianapolis serves as a hub for delivering our products just in time, every day. We are seeking a detail-oriented Quality Control Chemist to join our dynamic team.

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 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 test documents and method development validation protocols and reports.
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.
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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