Analyst II, QC Analytical-3rd-Shift

Job Summary

Perform analytical testing per cGMP in support of raw material, in-process, final product, stability. This position will support our 3rd shift operations, working 10pm-6:30am.

Essential Functions

• Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.
• Perform analytical work per method transfer/validation programs.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Perform instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography.
• Inform supervisor upon observing out of specification results.
• Perform moderately complex test methods such as ELISA, etc.
• Participate in investigations of OOS results and other related studies.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Write protocols and reports as necessary.
• Write and review SOP's and Testing Standards as necessary.
• Assist in training other Analysts.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in LIMS.
• Compiles trend analysis and write associated reports for internal and regulatory use.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Track time worked per project.
• Participate in meetings as required.

Minimum Education, Experience, Skills

• B.S. in chemistry or related field
• Minimum of 2-4 years in a GMP analytical chemistry laboratory

Technical/Professional Knowledge

• Problem Solving — identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
• Safety and Security — observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
• Communication — effective verbal and written communication, ability to complete daily tasks as assigned, ability to work independently and in a group, and ability to multi-task.
• Quality Management — looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
• Planning/Organizing — prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
• Adaptability — maintains effectiveness when experiencing major changes in work tasks or the work environment.