Quality Assurance Supervisor

• Reviews and approves documents and records in support of manufacturing includingvalidation documents protocols final reports and study design
• Serves as an SME on method development and validation in line with Quality by Design principals and ICHQ1-Q14
• Serves as a member of the Change Review Board
• Leads investigation teams
• Represents QA in internal and external audits
• Analyze documentation and perform gap assessments
• Manages team resources and scheduling to support scale-up and product improvement activities
• Coordinates with key stakeholders in the organization to ensure objectives are met and staff are properly developed and trained
• Collaborates effectively with a cross functional team to meet objectives and complete key initiatives
• Leads and inspires a diverse team of skilled professionals
• Establishes and maintains a technical direction and supervisory oversight structure for the team including career progression and succession planning
• 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

• 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
• Bachelors degree or equivalent in science engineering management or related field
• 8 years of relevant experience in quality compliance or MS&T 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
• Displays proven ability to lead and develop staff and teams
• Experience operating in a cGxP environment with the ability to apply best practices
• Subject matter expertise product and process development Quality by Design and regulatory expectations.
• 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)
• Displays excellent interpersonal written and oral communication skills
• Possesses strong organizational and project management skills for self and teams
• Demonstrates strategic thinking with creative and excellent problem solving and decision-making skills with ability to critically interpret and use data to manage risk

• Masters 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 material
• 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)

• Full-time position
• Niowaves standard operating hours are Monday 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 meet shift work requirements and to engage with staff working outside of standard hours as needed
• Niowave has multiple locations within the Lansing area and travel between locations is expected in the role

Required Experience:

Manager