Quality Control Scientist II (Alternative Shift)

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.