Scientist I – Analytical Operations – Co-Op Full-time

Job Title

Summary: Provide analytical support in the Laboratory Operations Department by following standard practices. Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicates test results.

Essential Functions:

• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Carry out independently HPLC, dissolution and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• Perform basic troubleshooting to overcome system suitability failures.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction.
• Maintain a safe working environment and report potential hazards.
• May be essential to perform alternating or rotating shift work (as required).

Required Qualifications:

• Education: High school diploma/General Educational Development (GED) Certificate is required Working towards B.Sc. in chemistry
• Experience: Previous experience in a science related environment.
• Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

• Good understanding of basic chemistry and experience with common laboratory equipment and operation.
• Good understanding of chromatographic seperations.
• Knowledge of qualitative and quantitative chemical or microbiological analysis.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Good problem-solving skills and logical approach to solving scientific problems.
• Demonstrable interpersonal and communication skills (both oral and written).
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
• Proficiency with the English language.
• Works well independently and in a team environment.