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 Reasonable accommodations will be made to enable individuals with disabilities to perform the 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. • Complies 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. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. 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- the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully. • Safety and Security-the individual 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, the ability to complete daily tasks as assigned, the ability to work independently and in a group, and the ability to multi-task. Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings. • 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; adjusting effectively to work within new work structures, processes, requirements, or cultures. Base Compensation Range: 75000-113000 Compensation and Benefits We offer a comprehensive benefits package designed to support our employees' wellbeing, including: • Competitive salary and performance-based incentives • Comprehensive health coverage including medical, dental, and vision insurance • Retirement savings plans with employer matching contributions • Paid time off • Professional development opportunities • Employee wellness programs and resources • Employee Assistance Program and Mental Health Resources