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YOUR CONTRIBUTION
- Participate in the development and execution of method transfers, equipment qualifications, and method validation activities as applicable.
- Perform analytical testing using instruments such as UHPLC, Mass Spectrometer, Densitometer, etc.
- Adapt, develop, or follow assay protocols and summarize results.
- Assist with analytical test method qualification and validation protocols.
- Follow all established laboratory, regulatory, safety, and environmental procedures. Adhere to the standards of quality rules by cGLP and the company Quality Policies and site SOP's.
- Author, review, and update SOPs as needed; understand and follow complex written procedures.
- Must follow good documentation practices in all aspects and phases of work; provide reports for review in a timely manner; collaborate with other lab personnel on projects.
- Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs daily.
- Material handling and inventory control, including controlled substances.
- Report all deviations and participate in the resolution of deviations and assignment of CAPA.
WHAT IT TAKES
- Post-Secondary education, preferably a University Degree (BSc.) in Chemistry or related field.
- Minimum of 1 year laboratory experience, preferably in a cGMP, GLP setting.
- Working knowledge of NIST standards.
- Chromatography or related experience is considered an asset.
- Ability to understand and follow complex written procedures.
- Excellent written and oral communication skills.
- Excellent organizational and analytical skills with a high attention to detail.
- Proficiency with Microsoft Office applications (Work, Excel, Outlook, etc.).