QC Chemist I

Performs specifically prescribed tasks of a routine nature to meet company and regulatory quality standards for a combination product (drug/device). Performs testing according to Standard Operating Procedures (SOPs). Exhibits basic knowledge of laboratory tests. Work is closely supervised and checked for accuracy, neatness and progression. Completes tasks accurately and timely.

• Independently performs analytical testing for some release and raw material testing according to SOPs and / or USP methods.
• Ensures that all equipment used for testing purposes is within calibration and preventative maintenance schedules.
• Ensures that all reagents and chemicals used for testing are being stored appropriately and are within their shelf-life or expiry.
• Clearly and accurately records data and supporting test information related to tasks performed in lab per GDP and data integrity requirements
• Contributes to summary reports & investigations
• Notifies management of any data excursions, such as out of specification results, equipment failures, and environmental conditions that could affect testing
• Performs daily, weekly or monthly equipment verifications, as assigned
• Adheres to all relevant lab safety rules / requirements for working in the laboratory as well as those specified for chemicals / reagents and equipment used for testing
• May be responsible for one or two areas of the lab, such as inventory management
• May train entry level employees on a few tasks and assays
• Other related duties as assigned

Academic Qualification: Associate Degree (Chemistry or related field)

Years of experience: 0-1 year

Laboratory Skills: understanding of basic chemistry

Quality Compliance / Good Lab Practice Experience: awareness of the importance of GxP practices (e.g. GMP, GLP, GDP, etc.)