QA Validation Specialist III (Biopharma)

Location: Andover, Massachusetts, United States; office setting with a standard Monday–Friday schedule

Annual base salary: $82,700–$137,900, plus eligibility for a 10% performance bonus

Company

hirify.global develops and delivers pharmaceutical products with a focus on safety, effectiveness, scientific quality, and risk-based compliance.

What you will do

• Provide quality assurance oversight for the Andover site validation program.
• Review and approve validation specifications, protocols, testing documents, summary reports, plans, and strategies.
• Review change controls, assess validation impacts, and identify testing needed to maintain the validated state.
• Support project teams with validation-related compliance and technical issues.
• Review investigations, commitments, procedures, and maintenance work orders related to validation.
• Resolve simple to moderate quality validation issues, support continuous improvement, and maintain inspection readiness.

Requirements

• Bachelor’s degree with at least 4 years of experience, master’s degree with at least 2 years, PhD with 0+ years, associate’s degree with 8 years, or high school diploma with 10 years of relevant experience.
• Strong understanding of validation principles, practices, regulatory requirements, and guidelines.
• Proficiency in project management, resource planning, computerized systems, and software applications.
• Ability to work independently and make decisions in ambiguous situations.
• Strong communication and interpersonal skills.
• Permanent U.S. work authorization is required; U.S. work visa sponsorship is not available.

Nice to have

• Knowledge of GMP regulations and guidance, including 21 CFR Parts 11, 210, and 211, EC Annex 15, and ICH 7.
• Experience with problem-solving, negotiations, data integrity, risk management, and matrixed project environments.
• Quality assurance, validation engineering, manufacturing, laboratory, or biopharmaceutical industry experience.
• Technical writing experience and familiarity with generative AI tools such as ChatGPT or Microsoft Copilot.

Culture & Benefits

• Standard Monday–Friday office schedule with little to no travel.
• Minimal off-shift support may be needed if issues arise.
• Benefits include 401(k) matching and retirement contributions, paid vacation, holidays, personal days, caregiver and medical leave, and medical, prescription, dental, and vision coverage.
• Relocation assistance is not generally included for this role, although it may be available based on business needs or eligibility.