Quality Assurance Specialist I

Niowave • Lansing, MI

13h

About The Position

Quality Assurance Specialist I 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 are a detail-oriented professional who thrives in regulated manufacturing environments. You are motivated by doing things the right way and take pride in supporting systems that keep products safe, compliant, and reliable. Words that describe you are organized, process-driven, collaborative, and curious. What you can expect to work on… The Quality Assurance Specialist I s upports key quality system activities including documentation, investigations, audits, and process improvements to ensure products are manufactured in compliance with cGMP and regulatory requirements. This role collaborates with production, engineering, and quality teams to maintain high standards of safety, quality, and operational excellence across Niowave’s manufacturing processes.

Requirements

• Embraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright Zeal
• Bachelor’s degree or equivalent in science, engineering, or related field
• 1+ years’ related experience or equivalent internship experience, with an understanding of regulatory compliance related to operations and quality procedures
• Basic understanding of pharmaceutical quality requirements, cGMP/GLP, and general regulatory expectations.
• Moderate proficiency in Microsoft Word (styles, table of contents, section breaks, formatting tools)
• Familiarity with PDF editing and publishing tools (Adobe Acrobat Pro)

Nice To Haves

• 2+ years’ related work experience
• Quality or Regulatory certifications (CQE, CQA, CQM, RAC) or willingness to pursue them
• Experience with lean manufacturing or continuous improvement tools (Six Sigma, Lean, 5S)
• Experience configuring and maintaining an electronic quality system
• Experience in a cGMP CDMO, API or Finished Drug environment
• Experience in a facility with radiation regulatory requirements and/or quality role in the pharmaceutical or medical device industry.
• Experience in audits (internal, NRC, FDA, etc.)
• Knowledge of the following regulations: ISO 13485, 21CFR 820, 21CFR 210/211, Nuclear Regulatory Commission (NRC)

Responsibilities

• Support configuration and training end-users on the electronic Quality System NCMRs, Complaints, OOS, Change Control, and CAPAs under guidance from senior team members
• Support data collection and author basic investigations with minimal guidance
• Assist with internal and external audits by preparing records, gathering evidence, and participating as needed
• Follow all Quality Systems requirements and support initiatives that contribute to Safety, Compliance, Quality, On-Time Delivery (OTD), and continuous improvement goals
• Support training activities for quality and operations personnel by maintaining training records and assisting with scheduling
• Serve as a point of contact for internal Quality System questions
• Contribute to quality for new or existing products through activities such as data collection, document drafting, test method execution support, or basic validation support (e.g., TMV, configuration acceptance testing, software, equipment, process, or product)
• Compile metrics for quality monitoring and management review

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level