Product Quality Operations Supervisor
Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
Who you are…
You have a collaborative approach to upholding rigorous standards for safety, quality, and efficiency. You’re passionate about mentoring others, solving complex problems, and driving operational excellence. You embrace leadership as a privilege and a responsibility, and you model a culture of respect, learning, and achievement. Words that describe you are understanding, resilient, and collaborative.
What you can expect to work on…The Product Quality Supervisor is responsible for overseeing quality assurance processes to ensure that all products manufactured at Niowave meet established standards and regulatory requirements, thereby maintaining high levels of customer satisfaction. Job satisfaction in a People Management role is measured by the synergy you instill in cross-functional team members, enabling them to achieve optimal outcomes.
- Reviews and approves documents and records in support of manufacturing, including batch release, stability, material, and environmental monitoring
- Provides onsite support during manufacturing activities, including managing escalations from Quality Technicians and production teams
- Ensures consistent application of cGxP requirements to manufacturing and release procedures
- Represents QA in internal and external audits
- Serves as a Subject Matter Expert (SME) in batch review and release
- Leads and inspires a diverse team of skilled professionals
- Within the department and across the organization, fosters a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization
What you need to succeed…
- Bachelor’s degree or equivalent in science, engineering, management, or related field
- 8+ years of relevant experience in quality, compliance, or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
- 3+ years of experience managing day-to-day activities of 6 or more team members, with demonstrated ability to build cohesive teams, establish career development tracks, and succession planning.
- Embraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright Zeal
- Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state
- Understands your own communication and learning styles, can assess others’ styles, and is able to find the right path to best connect with colleagues
- Experience operating in a cGxP environment with the ability to apply best practices
- Demonstrates strategic thinking with creative and excellent problem solving and decision-making skills with ability to critically interpret and use data to manage risk
- Subject matter expertise in manufacturing quality assurance processes and procedures
- Hands-on experience utilizing root cause analysis and continuous improvement systems (Six Sigma, Lean Manufacturing, 5S, statistical analysis and process control, process and value stream mapping, 5-Whys, fishbone/Ishikawa diagram, A3 Problem Solving
Great to have…
- Master’s degree in science, engineering, management, or related field
- 10+ years of relevant experience in quality, compliance, or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
- Experience with radioactive materials
- Experience with Minitab, JMP, or other analytical tools
- Previous medium to large scale project management experience
- Knowledge of one or more of the following regulations: 21CFR 210& 211, Nuclear Regulatory Commission (NRC)
Other things to note…
- Full-time position
- The company’s standard operating hours are Monday thru Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shifts
- This position will have regular working hours Monday-Friday with an expectation of adjusting to meeting the shift work requirements for production and to meet with staff working outside of the standards operating hours
- Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
