Location: Jupiter, FL
Reports To: CSTO
Reporting to the VP of Quality, the QC Technologist III performs routine Quality Control testing, maintains an organized, well-stocked laboratory environment, and assists in the development and validation of new analytical tests.
Alphazyme is committed to the continuous improvement of process efficacy and efficiency, in compliance with the FDA’s 21 CFR Parts 11 and 820, and the QC Laboratory Technologist III plays an integral role in this program.
Job performance will involve a variety of activities including:
- Incoming inspection testing of raw materials
- Accurate, on-time testing of newly manufactured product lots
- Timely completion of test result documentation
- Participation in Quality investigations
- Support enzyme development team. Responsibilities may include training on new techniques and performing in-process testing and final testing on research products
- Understand and adhere to regulatory and statutory requirements and standards
- Identify and implement Continuous Improvement efficiency improvements
- Daily walk of the lab spaces to ensure a neat, tidy, and well-stocked environment
- Maintain equipment database, assist in scheduling and coordinating preventive maintenance and calibration activities
- Determine and document specifications of materials in consultation with staff
- Assist in coordinating the use, storage and disposal of flammable, poisonous, corrosive or other hazardous materials; informs employees of the nature of hazardous materials, the policies and regulations governing their use and the use of safety equipment
- Assists in implementing safety procedures; preparing, revising and implementing the chemical hygiene plan
- Writing and revising procedures and work instructions
- Implement and maintain the inventory of chemicals, reagents and buffers; monitors the condition and status of dated or unstable chemicals;
prepares and maintains material safety data sheets
- Additional duties as assigned
- Minimum 2 years of experience in a scientific industry or academic setting
- Ability to follow documented work instructions and complete related forms
- Experience in a Good Manufacturing Practice (GMP) or ISO 13485 environment is desired
- Ability to organize tasks and work independently; ability to communicate effectively orally and
in writing; ability to use science literature and reference texts; ability to keep accurate records;
ability to work safely.
- Experience with molecular biology techniques
- Ability to adjust to a high-demand and fast-paced environment
- Bachelor’s degree in life science discipline such as Molecular Biology, Biochemistry or
Alphazyme was founded in 2018 by experts in the field of enzyme development and production with a track record of success and a passion for supporting innovators in molecular science. Our mission is to be the world’s premier partner for custom, industrial-scale molecular biology enzymes. We partner with the manufacturers of nucleic acid therapies and detection platforms to develop and produce affordable, reliable enzymes which meet the specifications of the rapidly expanding market for custom DNA and RNA molecules, genomic medicines and genetic tests. Consistent quality, scalable production, and compatibility with regulatory requirements are the hallmarks of our business.