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Argenta
Oakland, NE | Full Time
$75k-94k (estimate)
1 Month Ago
Pre-Clinical Senior Quality Assurance Officer
Argenta Oakland, NE
$75k-94k (estimate)
Full Time | Pharmaceutical 1 Month Ago
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Argenta is Hiring a Pre-Clinical Senior Quality Assurance Officer Near Oakland, NE

At Argenta we have a passion for what we do, and we relish a challenge.

About us

We are in the animal health business, partnering with our clients in the areas of Research and Development (R&D) and manufacturing to produce pharmaceuticals for both farm and companion animals. Originally founded in 2006 by a New Zealand chemist with an entrepreneurial mindset, Argenta’s vision is “Healthier Animals, Sustainably”. Our recipe for success has been our uniqueness in our vision and our people. Argenta now has operations across the globe with locations in New Zealand, the United States, Scotland, Germany, and Spain with 600 employees globally.

Argenta is looking for an experienced Pre-Clinical Senior Quality Assurance Officer to join our Argenta, MVS team.

The Pre-Clinical Senior QA Officer adds value through the following responsibilities: 

  • Perform QA reviews of Protocols, Monitor Plans, Data Management Plans, Final Study Reports, statistical analysis reports, intercompany Quality Agreements, and study support documents.
  • Perform qualification inspections/audits of selected vendors, laboratories, and clinical study sites
  • Maintain and assist in the management of QA systems and QA files for all studies that are assigned to Argenta, MVS QA oversight
  • Provide QA guidance to the team in line with Argenta procedures and applicable regulatory standards
  • Perform follow up reviews of audit findings to confirm corrective actions have been completed
  • Provide oversight and participation in inspections by regulatory agencies and clients
  • Maintain QA systems and QA files in an orderly fashion for quick retrieval of documents
  • Perform internal and external audits and/or inspections within identified timeframes

Pre-Clinical Senior QA Officer requirements:

  • Bachelor's degree, preferably in a scientific discipline or equivalent experience
  • Minimum of 5 years' experience in Good Laboratory Practice data management, quality control and/or quality assurance
  • Minimum of 5 years' experience in Good Clinical Practice data management, quality control and/or quality assurance
  • Experience conducting audits in study protocols in accordance with GLP guidance as well as laboratory GLP setup
  • Excellent oral and written communication studies
  • Strong analytical thinking and problem solving skills
  • Capable of working in a changing environment and under pressure

Why us? 

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 strong culture, great benefits, and opportunity for growth.

For more information visit us at www.argentaglobal.com 

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$75k-94k (estimate)

POST DATE

04/05/2024

EXPIRATION DATE

06/04/2024

WEBSITE

argentaglobal.com

HEADQUARTERS

FORT DODGE, IA

SIZE

25 - 50

FOUNDED

2006

CEO

DAVE PAARDSON

REVENUE

$10M - $50M

INDUSTRY

Pharmaceutical

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About Argenta

Healthy Animals. Let's Make It Happen, Together. At Argenta we've been dedicated to animal health from day one. Since 2006, we've been a trusted partner to clients who need our expertise, partnership and no-challenge-too-tough attitude to bringing innovative new animal health products to market. Because we are the only global CRO and CMO specializing in animal health, we are uniquely able to offer clients of all sizes a comprehensive product development solution from Molecule to Market, at any scale. The day-to-day ethos that drives our company forward is a mission focused on global partnershi ... ps, a Molecule to Market approach, and of course, innovation. At the core of our business and our organisation is collaboration among our global team and with our customers. Working together, we continually challenge ourselves and each other to continue to innovate to develop the best animal health technologies and products possible. From animal scientists to veterinarians to engineers and other industry experts, our 450+ strong global team is a passionate and diverse group united in their commitment to healthy animals. We operate from Research & Development locations in New Zealand and the US and (EMA and FDA) GMP approved Manufacturing sites in New Zealand, the United Kingdom (Scotland) and the United States (Fort Dodge, Iowa). Our company was founded in New Zealand by Doug Cleverly, a scientist who naturally felt more at home in the lab solving problems than in the boardroom. Doug imbued the company with the spirit of Kiwi ingenuity and a global perspective. He saw a need in the market for an animal health company that could provide the highest quality services to customers of all sizes, all over the world. To this day, we are still dedicated to animal health and our founder's legacy of problem solving and inventiveness lives on within the organisation. Lets get in touch! More
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