QA Engineer

Argenta; Shawnee (KS); On-site; USD 75,000 - 95,000; Full time

Job summary

Argenta is hiring a QA Engineer for our Shawnee, KS site to lead NCR investigations, drive CAPA actions, and ensure robust quality systems in support of animal health products.

You will collaborate with regulatory agencies, clients, and internal teams to resolve discrepancies, maintain quality documentation, and support audits and inspections. A science degree and cGMP experience are required.

Qualifications

• BS/BA in science (Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent related work experience.
• Minimum three+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices (cGMP).
• Experience with sterile manufacturing and/or laboratory testing is a plus.

Responsibilities

• Lead NCR investigations and determine root causes within defined timeframes.
• Draft clear, defendable investigations and root causes.
• Determine CAPAs to address NCR causes and set realistic completion dates.
• Interface with Customer Quality Organizations; act as liaison with clients for quality issues.
• Support internal and external audits and regulatory inspections.

Skills

cGMP auditing

Quality tools

Documentation control

Regulatory liaison

Interpersonal communication

Microsoft Office

Education

BS/BA in science

Tools

Document Control Systems

Quality databases

Job description

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