Senior Quality Assurance Specialist – Product Quality
Who we are…
We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, 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 precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent, efficient, diligent and technologically savvy. You also embrace change to keep pace with emerging information and shifting priorities, offering suggestions to improve process flows. You get great satisfaction from launching new products, improving compliance on existing products or procedures and rise to the occasion to take on miscellaneous projects. You easily transition between working independently to working with a team with excellent customer service as your internal guide.
What you will achieve…
- Lead or guide team on NCMR, Complaints and CAPA; lead and/or support Internal and External Audits.
- Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations and improve productivity.
- Participates in pre- and post-production reviews and approvals providing quality and regulatory support.
- Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed Niowave goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
- Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies.
- Support training management for quality and operations personnel.
- Acts as a customer liaison and processes customer quality complaints.
- Lead and manage quality involvement for the development of new products or sustaining products via validation methodologies such as TMV, equipment, process and product.
What you need to succeed…
- Bachelor’s degree or equivalent in STEM field
- 8+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems.
- Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management, Quality by Design or Technology Transfer.
- Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities.
- Experience with and working knowledge of cGMP and GLP quality systems.
- Embraces and models the Niowave 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 connect the two.
- Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams.
Great to have…
- Masters degree in STEM field
- Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC)
- 10+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems.
- Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S)
- Experience operating in a cGMP CDMO or Finished Drug environment.
Work Environment
- The company’s standard operating hours are Monday thru Friday 6a – 6p with production related activities requiring 24/7/365 shifts.
- This position will have regular working hours during M – F with an expectation of adjusting to work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Please provide a cover letter specifically describing the nature of your technical expertise.
