Job SummaryDeveloping 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
CompensationThe 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.
