Argenta was founded in 2006 by a New Zealand chemist with an entrepreneurial mind, his vision was to touch lives all over the world by the creation, development and production of the best animal health technologies and products. Our vision and our people are unique and are the key to our success to date. We have a global presence with locations in New Zealand, the United States, UK and Europe.
About the role
As QC Analyst you will play an important role within your team, developing your technical expertise to support our manufacturing business ensuring raw materials and finished products are tested to meet the highest level of quality standards and business requirements. Your development will bring over time a varied role, performing analysis, completing investigations, and validation testing activities. You'd be a key contributor supporting your team to close a number of team actions relating to CAPA/LIRs and change control/audit actions/SOP and method updates.
Experience
1. Pharmaceutical, laboratory or related environment awareness
About you
By nature, you are a solutions-orientated team player that takes a proactive approach to their work. You are a keen contributor and
Your background, experience and attributes will include:
2. Relevant tertiary qualification in Chemistry/Pharmacy/Biology
3. Ability to write standard operating procedures and conduct lab investigations with guidance
4. Ability to work to deadlines, multitask and manage your time effectively
5. Take pride in your attention to detail, understand the importance of a quality focused team and a willingness to learn and improve
6. Commitment to quality, standards, and integrity
7. Flexibility to work shifts Early 0700-1500 Day 0800-1600 Late 1330-2130
Key Responsibilities:
8. Perform analytical testing of raw materials, product packaging and final product to support the release, stability and in process testing of materials for production or products for commercial use
9. Accurately follow relevant SOPs, performing all activities in accordance with cGMP requirements, reporting anomalies. Initiate and complete laboratory discrepancy events on time
10. Document test results to ensure completeness and accuracy per cGMP, keeping accurate documentation. Complies, enters and reviews data into databases, evaluating and interpreting data
11. Demonstrates hands-on knowledge of operating, maintenance and troubleshooting skills for HPLC instruments as well as quality / regulatory requirements pertinent to quality control environments / laboratories. Performing moderate to complex equipment / instrumentation troubleshooting
12. Contribute towards the development and revision of SOPs, investigations, the preparation laboratory investigation reports and implement corrective & preventative actions (CAPAs)
13. Support departmental improvement projects related to release goals, the identification of root cause for investigations and the improvement of laboratory methods
14. Performs laboratory cleaning activities
15. Assist with addressing questions during audits (internal / external) and supports inspection related needs as required
16. Ensure compliance all tasks undertaken comply with site Standard Operating Procedures (SOPs) and the principles of cGMP
17. Comply with all company local and global policies
18. Perform any other duties or serve in such other capacity as may be determined by Company management
Qualifications:
19. HND or Degree in relevant scientific discipline
20. Experience in cGMP & global regulatory environment
21. Experience with chromatography systems & software is required
22. Ability to multi-task and adapt to changing business requirements in dynamin manufacturing/corporate environment
23. Demonstrated technology skills i.e. equipment; instrumentation & computers
24. Technical writing skills e.g. reports; SOPs and change controls
25. Excellent interpersonal, written and verbal communication skills
26. Demonstrated continuous improvement mindset