Quality Control Analyst I - SDF

Role Summary

The Quality Control Analyst I – SDF performs and reviews analysis of in-process, release and stability samples in accordance with cGMP, site and corporate procedures and policies. Transfer of technology and processes in accordance with relevant project plans and timelines. Reports to the Senior Manager, QC – OFP. Location: Durham, NC.

Responsibilities

• Accuracy & Scientific Soundness of Lab Data
• Environmental Compliance
• GMP Compliance of Laboratory
• Maintain testing proficiency for methods
• Timeliness of Lab Results & Investigations
• Analysis of Samples
• Supports Deviations
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• Required: Minimum of a Bachelor’s degree in chemistry or relevant field of study from an accredited university or an equivalent combination of education and experience
• Preferred: May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
• Preferred: May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
• Required: Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory
• Preferred: Ability to author scientific and technical reports
• Preferred: Able to perform routine testing per SOP & GMP standards
• Preferred: Basic troubleshooting for laboratory equipment
• Preferred: Knowledgeable in GMP and laboratory techniques
• Required: Must demonstrate attention to detail
• Preferred: Strong communication skills (verbal and written)
• Preferred: Chemistry – Analysis of tablets including UPLC and Dissolution

Skills

• Preferred: Chemistry analysis of tablets including UPLC and dissolution

Additional Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to do close precision work with hands
• Must be able to remain in a stationary position (sitting and standing) 50% of the time
• May require corrected vision to 20/25 based on role
• May require color vision based on role
• Occasionally ascends/descends a ladder
• May be required to work at elevated heights
• Occasionally works around odorous and/or hazardous materials