A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Quality Assurance Specialist will report directly to the local BioReliance Validation Services (BVS) Quality Manager, and will work directly with other BVS Quality Assurance staff, validation project coordinators, laboratory management, and the Global Support (GS) Extractables and Leachables (E&L) SME. Primary responsibilities are providing support to the E&L laboratory by reviewing test protocols and reports, laboratory records, raw data, computerized system and instrument qualification protocols and reports, and standard operating procedures. Additional responsibilities include oversight and approval of change controls, deviations, root cause investigations and CAPAs, issuance and accountability of worksheets and lab records, conducting self-inspection audits, leading continuous improvement initiatives and other duties as needed [RD1] under the direct supervision of the BVS Quality Manager.
Who You Are:
- Bachelor of Science (BS) degree and a minimum 3 years of experience working in a regulated environment (e.g. GxP) in a Quality role, master degree preferred
- Working knowledge of analytical methods development, validation and transfer
- Working knowledge of analytical instrumentation including HPLC, FTIR, GCMS and LC-Q-TOF
- Working knowledge of Waters Empower, Masshunter and TrackWise software preferred
- Experience leading test failure (i.e. OOS) investigations, deviations and CAPAs
- Understanding of risk management principles
- Proficient with Microsoft Word and Excel
- Excellent written and oral communication skills
- Strong organizational and time management skills
- Ability to read and review documents in both English and Chinese
- Comfortable working in a fast pace environment
- Demonstrate ability to adapt to change (process, tools, organization …)
- Team spirit and respectful behavior
- Positive attitude and mindset
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com