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Company

Original Job Post

Niowave, Inc. · 19 hours ago

Senior Quality Assurance Specialist/Quality Engineer

Lansing, MI

Full-time

Onsite

Senior Level

8+ years exp

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ManufacturingPharmaceutical

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Responsibilities

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.

Qualification

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Quality assuranceQuality controlPharmaceutical quality requirementsLifecycle managementQuality by designTechnology transferFederal lawsState lawsLocal lawsCGMPGLPMRPERP systemsNiowave ValuesIntegrationCommunication stylesLearning stylesProblem-solvingInterpersonalOrganizationalProject managementTeamworkCourageIntegrityQuality ManagementRegulatory ComplianceLean ManufacturingSix Sigma5SCDMO

Required

Bachelor’s degree or equivalent in Sciences or Engineering

8+ years of relevant quality system experience in pharmaceuticals

Experience in quality assurance or quality control roles within a manufacturing or industrial environment

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

Knowledge of procedures and tools for scheduling and controlling production runs and assuring quality deliverables E.g., MRP, ERP systems

Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams

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 their own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two

Preferred

Quality, Regulatory, and/or Project Management certifications are preferred (e.g., CQE, CQA, CQM, RAC, PMP)

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

3+ years of medium to large scale project management experience

Agile project management training/experience

5+ years experience of quality team/department experience

Company

Niowave, Inc.

Niowave is a domestic supplier of medical and industrial radioisotopes from uranium fission and stable targets.

Founded in 2005

Lansing, Michigan, USA

51-200 employees

https://www.niowaveinc.com

H1B Sponsorship

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