Quality Control Chemist

Isotopia USA•Westfield, IN

3d•Onsite

About The Position

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Control Chemist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family, a team, dedicated to our mission to deliver on our covenant with our customers.

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

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
Perform any other tasks related to analytical testing as necessary