Quality Control Scientist I or II

Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our Quality Control Department is seeking a Quality Control Scientist level I or II who performs and supports sample testing activities in the Quality Control laboratory, upholding GMP practices and timely completion of client deliverables.

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.
• Adheres to consistent and predictable in-person attendance.
• Responsibilities may increase in scope to align with company initiatives.

Required Skills and Abilities

• Hands-on lab experience.
• 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.
• Proficient with Microsoft Office Suite or related software.

Education and Experience

• All levels: Bachelor’s degree in a scientific discipline or related field.
• For a level I applicant, we are seeking 2 years of dedicated lab experience in addition to the science education. GMP setting experience not required but preferable.
• For a level II applicant, we are seeking 3 years of dedicated lab experience (including 2 years in a GMP setting) in addition to the science education.