Quality Control Analyst II (Chemistry)

Location: Durham, North Carolina, United States; onsite pharmaceutical manufacturing facility

Company

hirify.global is a global pharmaceutical and healthcare company developing and manufacturing treatments for diabetes, obesity, and other serious chronic diseases.

What you will do

• Perform and review analyses of in-process, release, and stability samples in accordance with cGMP and applicable procedures.
• Analyze tablets using chemistry methods including UPLC and dissolution testing.
• Support technology and process transfers according to project plans and timelines.
• Maintain testing proficiency, laboratory data accuracy, equipment validation, and laboratory IT systems.
• Author deviations, support change control activities, investigate issues, and perform data trending.
• Coach other analysts and help keep departmental documents current and standardized.

Requirements

• Bachelor’s degree in Chemistry or a relevant field, or an equivalent combination of education and experience.
• At least three years of experience in a clinical, industrial, or pharmaceutical laboratory.
• Alternatively, an Associate’s degree with at least three years of relevant laboratory experience, or a high school diploma/GED with at least five years of relevant laboratory experience.
• Strong attention to detail and ability to perform routine testing according to SOP and GMP standards.
• Ability to move equipment or supplies weighing up to 33 pounds and perform close precision work.
• Ability to work around hazardous or odorous materials and occasionally at elevated heights.

Nice to have

• Experience with scientific and technical report writing.
• Knowledge of GMP, laboratory techniques, change control, deviations, and data trending.
• Experience with laboratory equipment troubleshooting, validation, or technical transfers.
• Strong verbal and written communication skills.

Culture & Benefits

• Paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an individual company match option.
• Paid parental and family medical leave.
• Tuition assistance, life and disability insurance, and access to hirify.global-marketed pharmaceutical products.