Our client is currently seeking a driven and ambitious Stability Coordinator to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.
1) Ensure compliance of the product stability program with international regulatory guidelines
2) Administer all product stability programs
3) Generate and analyze trend data using relevant statistical packages and escalation of trends to management
4) Present and distribute data and information generated by the product stability programs
5) Supervise the annual product reviews for licensed products in accordance with EU and US legal requirements
6) Generate detailed written reports and presentation of laboratory data
7) Independently design, plan and manage own studies identifying and developing appropriate stability indicating methods
8) Generate regulatory submission data to support changes to expiry dates for biologics
9) Perform routine duties as required in quality control laboratories in order to ensure the timely generation of accurate data and information
10) Ensure all activities follow Standard Operating Procedures and protocols where appropriate and are performed in compliance with GxP
11) Maintain and develop up-to-date knowledge on stability regulatory expectations
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biotechnology industry is strongly preferred
4) Preference will be given to people who have recent experience in regulatory
If you find yourself to be a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.