Senior Quality Control Specialist

Niowave • Lansing, MI

3h

About The Position

The Senior Quality Control (QC) Specialist provides oversight to ensure the safe and effective testing of pharmaceutical products manufactured at Niowave, Inc. This role is responsible for quality control oversight and direction for incoming material inspection and testing, environmental monitoring sampling and testing, product stability monitoring and testing, and batch release testing. The Senior QC Specialist ensures that all projects and testing activities are completed in compliance with applicable regulatory requirements. Monitor and maintain the QC state of inventory, quality, equipment, maintenance, calibration, and facilities to ensure they comply with Quality Systems and cGMP requirements Drive quality and compliance, adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowave’s goals for quality, safety, compliance, on-time delivery (OTD), and financial objectives Lead new or revised validation of test methods, monitoring processes, and equipment as needed Develop, author, and revise QC standard operating procedures, work instructions, test methods, protocols, and reports Develop QC operational readiness plan and support hiring plan to implement a QC team to support multiple facilities Initiate, review, and approve non-conforming material reports (NCMRs), investigate deviations, investigate laboratory out-of-specification (OOS), and write and implement corrective and preventative action reports (CAPAs)

Requirements

• Bachelor’s degree or equivalent in science, engineering, or related field
• 8+ years’ relevant experience in quality, compliance, or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
• Experience operating in a cGxP environment with the ability to apply best practices
• Experience implementing QC teams and operations with guidance from current operational excellence tools, e.g. Six Sigma, 6S and PDCA
• Hands-on experience utilizing root cause analysis and continuous improvement systems
• Substantive knowledge of applicable pharmaceutical regulations, including working knowledge of Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 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

Nice To Haves

• Master’s degree or equivalent in science, engineering, or related field
• 10+ years’ relevant experience in quality, compliance, or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
• Experience with Minitab, JMP, or other analytical tools
• Experience with ERP and/or LIMS systems
• Experience in team status and reporting tools, e.g. Project, Smartsheet, PowerBI, etc.
• Previous medium to large scale project management experience
• Knowledge of the following regulations: ISO 13485, 21CFR 820, Nuclear Regulatory Commission (NRC)
• Quality Certifications, e.g. ASQ SSGB, SSBB, CQA, CQE, etc.

Responsibilities

• Monitor and maintain the QC state of inventory, quality, equipment, maintenance, calibration, and facilities to ensure they comply with Quality Systems and cGMP requirements
• Drive quality and compliance, adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowave’s goals for quality, safety, compliance, on-time delivery (OTD), and financial objectives
• Lead new or revised validation of test methods, monitoring processes, and equipment as needed
• Develop, author, and revise QC standard operating procedures, work instructions, test methods, protocols, and reports
• Develop QC operational readiness plan and support hiring plan to implement a QC team to support multiple facilities
• Initiate, review, and approve non-conforming material reports (NCMRs), investigate deviations, investigate laboratory out-of-specification (OOS), and write and implement corrective and preventative action reports (CAPAs)

What This Job Offers

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