QA Engineer

Posted 6 Days Ago
Shawnee, KS, USA
In-Office
Mid level
Professional Services • Biotech • Pharmaceutical
The Role
QA Engineer responsible for NCR investigations, root-cause analysis, CAPA development, document approvals, media fill oversight, audits, inspections, quality agreements, customer quality liaison activities, compliance training, and continuous quality improvement within a pharmaceutical manufacturing environment.
Summary Generated by Built In

At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. 


Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. 

We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. 

Our uniqueness means: 

  • We are ambitious, growing and building a ‘one team’ culture, guided by our values.  
  • We are team players; 
  • We are doers; 
  • We are customer-centric; 
  • We are innovators. 

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better. 

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together. 


TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.  


Argenta is currently looking to fill the role of QA Engineer for our Shawnee, KS site.

Key Responsibilities: 


  • NCR investigations: Identify team members associated with NCRs, schedule meetings and lead the team through deliberate process to achieve completion of complex investigations including determination of the NCR root cause within the time requirements defined in procedures. 
  • Supports the writing of clear and defensible investigations and  defined root causes. 
  • CAPAs: Collaborated with the team to determine appropriate CAPAs to address the cause of the NCR to ensure no reoccurrence. Lead the team in identification of setting realistic due dates for completion of CAPA actions. 
  • Document/record approvals 
  • Support Media Fill QA Oversight 
  • New Project support 
  • Interface with Customer Quality Organizations. Act as the Liaison between Argenta and the client for all Quality related issues. 
  • Resolve discrepancies between clients and Argenta 
  • Review and provide input to client Quality Agreements 
  • Support Internal and External Audits 
  • Support Regulatory and Customer Inspections 
  • Drive quality improvements with customers, internal and external, to implement effective quality planning tools, measurement systems and other process controls 
  • Support Compliance Training
  • Coach colleagues to facilitate a focused knowledge transfer regarding the conduct of quality NCR investigations 

About You: 


  • BS/BA Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent related work experience required. 
  • Minimum three+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices. Experience in manufacturing, validations, quality systems and cGMP auditing. 
  • Relevant operations experience in the pharmaceutical industry. 
  • Experience in Sterile Manufacturing and/or Laboratory testing a plus. 
  • Working Knowledge of Document Control Systems and databases 
  • Exceptional knowledge of drug regulations (cGMPs) requirements as well as strong interpersonal, written, and verbal communication skills and be able to interface positively with Regulatory Agencies, Vendors and Company departments.
  • Manages objectives and balances commitments to prioritize and complete activities within established timelines. 
  • Ability to drive results and influence others outside their direct authority
  • Demonstrates confident, effective and adaptable communication skills to internal and external customers 
  • Experience with Quality tools, e.g. Cause and Effect Diagrams, Pareto Charts 
  • Fluent in Microsoft programs

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued.  At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.


Argenta is an equal-opportunity employer


To find out more about Argenta, click here: www.argentaglobal.com

Skills Required

  • Bachelor’s degree in a science field such as Biology, Microbiology, Chemistry, or Pharmacy, or equivalent related work experience
  • At least three years of pharmaceutical or related experience with emphasis on current Good Manufacturing Practices
  • Experience in manufacturing, validations, quality systems, and cGMP auditing
  • Relevant pharmaceutical operations experience
  • Experience with sterile manufacturing and/or laboratory testing
  • Working knowledge of document control systems and databases
  • Knowledge of drug regulations and cGMP requirements
  • Strong interpersonal, written, and verbal communication skills
  • Ability to interface with regulatory agencies, vendors, and company departments
  • Ability to prioritize objectives, balance commitments, and complete activities within established timelines
  • Ability to drive results and influence others without direct authority
  • Experience using quality tools such as cause-and-effect diagrams and Pareto charts
  • Fluency in Microsoft programs
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
1,000 Employees
Year Founded: 2006

What We Do

Argenta is a global animal-health contract research, development, and manufacturing organization (CRO/CDMO). Founded in 2006, it helps companies develop and manufacture health products for pets and livestock, providing support from molecule to market through pharmaceutical and biological development, regulatory affairs, clinical research, and manufacturing. Operating across New Zealand, the United States, the United Kingdom, and Europe, Argenta’s mission is to improve animal health.

Similar Jobs

In-Office
Lenexa, KS, USA
832 Employees

Photon Logo Photon

Quality Assurance Automation Engineer

Agency • Information Technology
In-Office or Remote
2 Locations
5017 Employees
37K-132K Annually
In-Office
Overland Park, KS, USA
1919 Employees

Photon Logo Photon

Quality Assurance Engineer

Agency • Information Technology
In-Office or Remote
2 Locations
5017 Employees
37K-132K Annually

Similar Companies Hiring

Fora Thumbnail
Agency • On-Demand • Professional Services • Sales • Software • Travel • Hospitality
New York, NY
250 Employees
Energy CX Thumbnail
Greentech • Professional Services • Business Intelligence • Consulting • Energy • Financial Services • Utilities
Chicago, IL
150 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account