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Quality Assurance Specialist II
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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 individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation i.e., GxP. Works across all Quality teams as part of strategic Q-Flex team.
The individual’s responsibility is to contribute to or impact the results of the Quality Assurance (QA) team and is accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or solves problems of low complexity independently by identifying and selecting solutions and by analysing information.
- Review and approve standard operating procedures (SOPs), laboratory / batch records and other quality records.
- Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
- Review and approve validation files for systems and assays.
- Review and approve minor, major and critical impact deviations / OOS records.
- Review and approve change control (GCC) records.
- Conduct trend analysis for deviations and review / approve applicable CAPA records.
- Conduct laboratory inspections to include commissioning and/or internal audits.
- Provide support for client regulatory submissions, client audits, external meetings and supplier audits.
- Review and approve client and supplier quality agreements.
Who you are:
- Degree in Life Sciences/Biology/Biotechnology or higher related degree
- Minimum of 3 – 5 years of experience, within Quality Assurance in a GxP environment
- Awareness of Biologics regulatory environment and GMP manufacturing topics.
- A proactive approach to all aspects of Quality.
- Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
- Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
- Strong analytical and problem-solving abilities.
- Organized and logical in defining workload and delivering projects.
- as a team player, cooperative, easily gains support of peers, encourages collaboration
- Global mindset and to be willing to engage in conference calls at out-of-office hours.
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