Quality Assurance Compliance Officer
2 weeks ago
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 organisation (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 650+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.
Argenta is looking for an experienced Quality Assurance Compliance Officer to join our Clinical R&D team.
About the job:
- Maintain and assist in the management of QA systems and QA files for all studies that are assigned to Argenta Clinical R&D QA oversight
- Perform QA reviews of Protocols, Monitor Plans, Data Management Plans (DMP), Final Study Reports (FSR), statistical analysis reports, and study support documents
- Perform QC reviews of raw data, data bases, draft and final study reports (FSR), Protocols, Monitor Plans, Data Management Plans (DMP), statistical analysis reports, and study support documents
- Provide support to fellow QA team members when inspected by regulatory agencies and clients
- Manage and maintain qualified Investigator/clinical site spreadsheet and certification files
- Assist in compliance training on GCPs, GLPs, and SOPs as required
- Serve as primary SOP Administrator, may assist in coordinating activities with Argenta Clinical R&D Management, to perform, document, and track periodic review and training of all SOPs (includes Guidelines Procedural Policies, Intercompany agreements, Business Continuity Plan(s), etc.)
- Perform QA inspections of received study drug supplies for regulatory, protocol, and SOP compliance with handling, storage, inventory, shipping, and labelling requirements
- Perform QA inspections of labelling and packaging runs for clinical supplies according to Sponsor approved instructions and batch records, and release with QA approval
- Manage and maintain QA files for all studies and labelling and packaging runs that are assigned for QA oversight
Qualifications
- Bachelor’s degree, preferably in a scientific discipline or equivalent experience
- Minimum of 2 years’ experience in a scientific discipline and/or veterinary/veterinary technician experience, is preferred
- Experience in quality control or monitoring activities is preferred
- Experience in Good Clinical Practice (GCP) data management, quality control and/or quality assurance is preferred
- Experience working with EDC systems (Electronic Data Capture) is a plus
- Position requires significant computer skills including the ability to use Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
- The employee must possess a valid driver’s license and proper travel documentation i.e., passport, and have the ability to travel
- A collaborative working style to be able to lead and motivate people at all levels and across all functions in an organization
- Excellent oral and written communication skills
- Strong analytical thinking and problem-solving skills
- Capable of working in a changing environment and under pressure
- Supports organizational goals and objectives aligned to strategic and/or operations plans
- Gathers key information essential to the planning and process of clinical trial management
- Works collaboratively with key stakeholders to streamline operations for maximum efficiency, automation, and effectiveness where appropriate
- Makes clear, concise, and convincing presentations to individuals or groups
- Explains issues and interprets data in understandable terms and adapts communication to target audiences
- Position does require occasional travel
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.
This position does report to the Lawrence, KS office daily.
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