Quality Assurance Specialist (Biotech)

Location: 100% onsite, Monday–Friday, in Milford, Massachusetts; local candidates only

No salary information provided.

Company

hirify.global develops reagent solutions with a focus on consistent quality, regulatory compliance, and personalized customer service.

What you will do

• Maintain the Quality Management System in accordance with applicable regulatory and industry requirements.
• Review batch records, in-process forms, protocols, and quality records for accuracy, completeness, and Good Documentation Practices compliance.
• Create and verify Certificates of Analysis and support the release or rejection of raw materials, intermediates, packaging, labeling materials, and finished products.
• Obtain and review vendor documentation, including Certificates of Analysis, Safety Data Sheets, and BSE/TSE statements.
• Support investigations and reporting for deviations, NCRs, CAPAs, customer complaints, and root-cause analysis.
• Prepare documentation for internal and external audits and assist with follow-up actions.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent.
• 3–5 years of relevant experience.
• Knowledge of ISO 13485, ISO 9001, and GMP is preferred.
• Ability to recognize deviations, recommend corrective actions, maintain accurate records, and follow procedures precisely.
• Strong written and verbal communication skills, attention to detail, organizational ability, and proficiency with Microsoft Office.
• Ability to work onsite in Milford, Massachusetts, Monday through Friday; local candidates only.

Nice to have

• Strong knowledge of chemistry.
• Experience developing and organizing information-management systems.

Culture & Benefits

• Work directly with Quality, production, commercial, and management teams.
• Contribute to product quality, regulatory compliance, and customer satisfaction.
• Support continuous improvement of QMS documentation and quality processes.