Quality Control Analyst I

Role Summary

Perform and review 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.

Responsibilities

• Accuracy and scientific soundness of lab data
• Environmental compliance
• GMP compliance of laboratory
• Maintain testing proficiency for methods
• Timeliness of lab results and investigations
• Analysis of samples
• Supports deviations
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

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

Additional Requirements

• Physical requirements: Moves equipment and/or supplies weighing up to 33 pounds; ability to perform close precision work with hands; ability to remain stationary (sitting and standing) 50% of the time; may require corrected vision to 20/25; color vision may be required; occasionally ascends/descends a ladder; may be required to work at elevated heights; occasionally works around odorous and/or hazardous materials.