QA Specialist II (Biopharmaceuticals)

Location: USA - NC - Durham - Emperor Blvd; on-site role

Company

hirify.global provides biopharmaceutical development services in a CGMP-regulated environment.

What you will do

• Perform compliance reviews of release, in-process, and stability testing data.
• Review and approve method qualifications and validations.
• Review and approve laboratory investigations and deviations associated with biopharmaceutical development.
• Interpret technical procedures, professional journals, and governmental regulations to support quality decisions.
• Prepare reports, business correspondence, and procedure manuals, and present information to managers, clients, customers, and other audiences.

Requirements

• BS degree with 11+ years of experience or MS degree with 8+ years of experience in a CGMP-regulated biopharmaceutical environment or equivalent.
• Experience reviewing analytical data, including release, in-process, and stability data.
• Experience reviewing method qualifications and validations, laboratory investigations, and deviations.
• Knowledge of USP, EU, and JP cGMP guidelines.
• Ability to apply basic algebra and statistics, solve practical problems, interpret varied instructions, and communicate effectively.
• Ability to sit for extended periods and lift up to 20 pounds; proficiency with word processing, databases, spreadsheets, presentations, email, calendars, and other computer tools.

Culture & Benefits

• Full-time employment at a biopharmaceutical development organization.
• Employees entering a KBI site in the US must report their vaccination status and provide proof of an FDA-approved or authorized COVID-19 vaccination when vaccinated.
• Equal opportunity and affirmative action employer committed to workforce diversity.