Duties and Responsibilities
- Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
- Performs routine extractions for dissolution, assay, and impurities testing
- Performs routine testing using analytical equipment including but not limited to KFC, dissolution apparatus, water activity, FTIR, etc.
- Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements
- Drafts stability tables, sets-up stability studies, logs-in samples and standards
- Cleans lab and glassware and disposes of analytical waste appropriately
- Participates in process improvement and other non-routine projects
- Conducts peer review of routine testing at the discretion of management
- Performs hypothesis testing or investigative work for OOS results under management and SME guidance
- Trains and mentors staff on established processes and procedures
- Demonstrates cross-functional support capabilities with other QC teams
- Responsibilities may increase in scope to align with company initiatives
- Performs other related duties as assigned
Required Skills and Abilities
- Proven analytical instrumentation experience (preferably HPLC) with at least 1-2 years in a cGMP pharmaceutical industry laboratory
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
- Follow detailed written and oral instructions
- Demonstrated ability to collaborate and work in cross-functional teams
- Strong organizational skills and attention to detail
- Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
- Strong analytical and problem-solving skills
- Accepts feedback from a variety of sources and constructively manages conflict
- Ability to prioritize tasks and to keep leadership apprised of performance to timelines
- Experience with Empower preferred
- Proficient with Microsoft Office Suite or related software
Education and Experience
- Bachelor’s degree in a scientific discipline or related field
- Minimum of 3 years of dedicated lab experience
- Requires 2 years of GMP experience
Physical Responsibility
- Prolonged periods of sitting or standing at a desk and working on a computer.
- Prolonged periods of standing or sitting while monitoring laboratory equipment.
- Must be able to lift up to 15 pounds at times.
- Adheres to consistent and predictable in-person attendance.