What are the responsibilities and job description for the QA Shop Floor Specialist position at Evergreen Theragnostics?
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
Description :
The position is responsible for overseeing quality activities related to radiopharmaceutical manufacturing and testing operations on the shop floor, at Evergreen Theragnostics, Inc. (Evergreen), to ensure compliance with Evergreen SOPs, and applicable local Health Authority regulations. Functional responsibilities include ensuring manufacturing, quality control, and materials storage adherence with applicable procedures, batch records, and other Evergreen GMP documentation, while providing concurrent review of documents directly related to, or associated with, manufacturing and analytical operations for the release of radiopharmaceutical products. This position will also work closely with operators in the manufacturing and analytical departments, as well as Quality Management, to ensure compliant and timely resolution of issues encountered on the shop floor during routine operations.
Responsibilities :
- Ensure manufacturing, materials storage, and analytical lab compliance with applicable SOPs.
- Perform Weekly GMP walkthroughs independently, and with Quality Management Personnel on a periodic basis.
- Must have strong written and oral communication skills, as well as the ability to critically review and interpret quality event investigations.
- Knowledge of quality risk management strategies, as well as demonstrated ability to continuously improve the Evergreen QMS and manufacturing / testing operations.
- Initial processing and review of quality events (QE) encountered on the shop floor.
- Review of all logbook entries in the manufacturing and analytical areas of the facility daily.
Knowledge & Skills :
Basic Requirements :
