Quality Control Scientist II — cGMP Lab, HPLC & Stability

Seranbio; Bend (OR); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Life insurance

Long-term disability

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience is seeking a Quality Control Scientist II to support an extended manufacturing schedule in a cGMP lab environment. You will perform routine testing, operate analytical equipment (preferably HPLC), manage data records, and contribute to process improvement initiatives.

The role requires at least 3 years of lab experience and GMP exposure, with a schedule on a late-day swing shift. Strong attention to detail and cross-functional collaboration are essential to ensure manufacturing

Qualifications

• Bachelor’s degree in a scientific discipline or related field.
• Minimum of 3 years of dedicated lab experience.
• Requires 2 years of GMP experience.
• Prolonged periods of sitting or standing at a desk and working on a computer.

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 HPLC, 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.

Skills

HPLC experience

Analytical instrumentation

Data record management

Cross-functional collaboration

Communication skills

Microsoft Office

Education

Bachelor’s degree in a scientific discipline

Tools

Empower

Microsoft Office Suite

Job description

Serán BioScience is seeking a Quality Control Scientist II to support an extended manufacturing schedule in a cGMP lab environment. You will perform routine testing, operate analytical equipment (preferably HPLC), manage data records, and contribute to process improvement initiatives.

The role requires at least 3 years of lab experience and GMP exposure, with a schedule on a late-day swing shift. Strong attention to detail and cross-functional collaboration are essential to ensure manufacturing