QC Analyst II

Job Summary Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. Responsibilities Provide timely analyses to support manufacturing and stability. This includes routine analyses of raw materials, in process and release of commercial product or clinical supplies Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications Provide accurate, written documentation of all work, including detailed observations and conclusions. Under general guidance, participate in laboratory investigations Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working environment Skills required Well-organized, capable of multi-tasking, and able to collaborate with individuals in a matrix environment Extensive hands-on experience performing relevant analytical techniques (HPLC, GC, FTIR). Experience with EMPOWER a plus Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on problem solving Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc. Knowledge of validation requirements for QC methods and regulatory guidelines Education and Experience Minimum Requirements Bachelor's Degree in science or related field 2-5 years relevant experience in a cGMP pharmaceutical QC environment, or at least 1 year with a Master's degree Physical Requirements Prolonged periods of sitting at a desk and working on a computer Potentially prolonged periods standing Must be able to lift up to 15 pounds at times Must be willing to travel Compensation The base salary for this role starts at $41/hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.