Job Description:

You will be responsible for manufacturing products for the Bulk Formulations TDM team and complete associated cGMP documentation. You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvement projects.

What will you do?

• Manufacture products including reagents, calibrators, buffers, controls, etc. and complete batch records while maintaining cGMPs and GDP standards
• Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release
• Review other manufacturing operators/scientist’s batch records
• Maintain and analyze lot histories for trends and discrepancies
• Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
• Participate in process improvement projects to improve operational efficiencies and support business needs
• Modify SOPs, work instructions and reports with mentorship
• Initiate and support investigations for quality documentation including NCARS, CAPAs, and Variances
• Maintain and troubleshoot testing and formulations equipment as appropriate
• Keep department supervisor and/or manager updated on all issues
• Perform other job duties as the need arises

How will you get here?

Education

BS/BA in a scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted

Experience

• 1 years of related experience and/or training preferred
• Laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
• Experience in working with potentially hazardous chemicals and human source materials preferred
• Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
• IVD immunoassay manufacturing experience preferred
• Knowledge, Skills, Abilities
• Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
• Must be organized, detail-oriented, and can prioritize own and other’s work to meet business efficiency metrics
• Self-sufficient, self-motivated, and focused
• Ability to routinely lift 25 pounds