Quality Control Scientist II

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.

Benefits