Quality Control Analyst III

Role overview

Responsibilities

• Perform complex testing and data evaluation, including TGA, liquid and gas chromatography, and UPLC; troubleshoot testing issues.
• Participate in or assist with test method validations and evaluate data for trends.
• Support out-of-specification investigations and complete CAPA requirements.
• Coordinate testing at outside laboratories and work with departments on testing needs and schedules.
• Maintain accurate records and execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries.
• Use risk assessment and root cause tools; support laboratory equipment upkeep and method troubleshooting.
• Train on methods, equipment, and SOPs; provide training to others and attend internal or external training.
• Enter, track, trend, compile, and summarize data; prepare and order supplies as needed.
• May lead departmental projects, cross-functional teams, continuous-improvement initiatives, customer teams, or the stability program.

Qualifications

• Bachelor’s degree in Chemistry or a related field.
• Minimum 5–7 years of pharmaceutical experience, or equivalent combination of education and experience.
• Experience in a cGMP or GLP pharmaceutical environment is preferred.
• Strong verbal and written communication, organization, time management, and ability to work under pressure with limited supervision.
• Ability to analyze and interpret technical, regulatory, and mathematical materials; write reports and procedures; and draw conclusions from data.
• Proficient with Microsoft Office and instrument-manufacturer software.
• Knowledge of FDA GMP requirements, including applicable 21 CFR parts; ISO 9001 and ISO 13485 are a plus.

Compensation

• Pay range is $84,000–$95,000 per year.
• Education, experience, location, tenure, and internal equity may be considered when offers are made.

Benefits

• Benefits include medical options, paid training, vacation and holidays, education reimbursement, a 401(k) matching program, and a learning platform.