Niowave, Inc.
Product Quality Operations Supervisor – Niowave, Inc.
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Product Quality Operations Supervisor
role at
Niowave, Inc.
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 make 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.
Responsibilities
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
Fosters a culture of respect, safety, quality, and continuous improvement aligned 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, knows how and when to make suggestions, and uses the right pace to reach an 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
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 shift work requirements for production and to meet with staff working outside the standard operating hours
Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
Please provide a cover letter specifically describing your expertise and leadership experience.
Seniority Level:
Mid-Senior level
Employment type:
Full-time
Job function:
Management and Manufacturing
Industries:
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Product Quality Operations Supervisor
role at
Niowave, Inc.
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 make 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.
Responsibilities
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
Fosters a culture of respect, safety, quality, and continuous improvement aligned 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, knows how and when to make suggestions, and uses the right pace to reach an 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
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 shift work requirements for production and to meet with staff working outside the standard operating hours
Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
Please provide a cover letter specifically describing your expertise and leadership experience.
Seniority Level:
Mid-Senior level
Employment type:
Full-time
Job function:
Management and Manufacturing
Industries:
Pharmaceutical Manufacturing
#J-18808-Ljbffr