QA Shop Floor Specialist

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:

• Possess thorough understanding of FDA-regulated pharmaceutical manufacturing and testing operations.
• Skilled at initial interpretation of issues, and effectively communicating such issues to Upper Management for further consideration.
• Must manage issues across multi-disciplinary Teams of employees for effective and efficient resolution(s).
• Ability to lead quality initiatives that enhance site QMS, and adjacent activities.
• Must be proactive and possess proficiency in decision-making, problem solving, conflict management, planning and organizing, resource allocation, and training.
• Ability to work efficiently when working independently on quality-related tasks.
• Ability to implement large-scale and complex corrective and preventive actions on the shop floor, with assistance from cross-functional team members.
• Ability to quickly recognize conflicts/issues and notify management with proposed recommendations for resolution.
• Must be able to verbally communicate updates, problems, projects, and any required information clearly to all audiences.
• As this job involves working within proximity to radiation, the individual must have a “safety-first” mindset.

Basic Requirements:

• Bachelor’s degree in STEM field – an equivalent combination of education and experience may be considered.
• 2 years of work experience within a GMP environment(s)
• Familiarity with pharmaceutical manufacturing and analytical lab operations.
• Work is performed in a combination of manufacturing cleanroom (aseptic gowning validation required), quality control analytical testing labs, materials storage facilities, as well as office environments.
• Work may be seated, standing and or walking for up to 50% of the time.