Senior Quality Assurance Specialist

• 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.

• Bachelors 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.

• 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 companys 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.
  

Required Experience:

Senior IC