Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

Job Description

When your part of the team, you’ll do important work, like helping customers with finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. As a Manufacturing Quality Leader you’ll help ensure quality products are delivered to our customers safely and on time. You will partner with the production team to tackle problems, improve processes and ensure that our quality management system (QMS) continues to mature with changing customer and regulatory expectations! 

  

How will you make an impact? 

Leading the Quality Control Technicians inspecting final product Single Use Systems to be used by our customers to manufacture lifesaving drugs or biotherapies. These final products will be used by the highly regulated biopharmaceutical industry and must be delivered on time with the highest quality. Your oversight of the QC team who conducts the in-process and final inspection of these crucial products is a critical component of the sites QMS and the overall integrity of the final product. Furthermore, it is a crucial element to the site's ability to deliver products on time efficiently and profitably. 

  

Position Summary:  
Support advancement of proactive quality initiatives and projects such as Design for Manufacturability, QC Optimization, and Defects Review Board. Act as a delegate to 

Supervise and develop QCTS. This position is in a 24hr production facility and may have responsibilities across multiple shifts. This position requires a successful candidate to Supervise, Train, Mentor, Identify and Solve problems, and support QC team management. 

  

Responsibilities: 

 

Assign QCTs to various Value Streams as the need arises and according to production/inspection demand. 

Perform trending of in-process QC data 

Support advancement of proactive quality initiatives and projects such as Design for Manufacturability, QC Optimization, and Defects Review Board 

Problem Solving – support customer complaints / atypical event management 

Document Management – draft, edit review standard operating procedures (SOP’s) and testing protocols 

Testing – establish, optimize and execute test methods and test protocols 

Continuous Improvement – apply practical process improvement (PPI) methodology to improve in the areas of quality, safety and efficiency 

New Product and Process development – work closely with engineering to implement new products and processes 

Auditing to site QMS, ISO 13485 and FDA 21 CFR 820 standards 

  

Required Qualifications: 

2-year associate degree 

2+ year(s) experience in supervising others 

Excellent writing and interpersonal skills 

Ability to interface well with all other working levels 

  

Preferred Qualifications: 

Experience in Manufacturing Environment 

Technical Writing Experience 

Working knowledge of Root Cause Countermeasures process 

Knowledge of ISO13485 

Knowledge of FDA 21CFR820 

Ability to read and understand CAD drawings 

Understanding of Metrology 

Experience with cGMP manufacturing 

Lean Six Sigma Understanding 

Bachelor’s degree from an accredited higher learning program with majors in science or business-related field. 

  

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