A biotechnology company in Massachusetts is looking to add a new Quality Assurance Specialist to join their growing team.

Responsibilities:

• Assist in the development, implementation, and maintenance of the quality management system (QMS)
• Manage document control processes, including document creation, review, approval, distribution, and archival
• Maintain and update quality documents, standard operating procedures (SOPs), and records
• Coordinate audit preparations and responses, ensuring timely closure of audit findings
• Investigate and assess non-conformances, deviations, and incidents
• Assist in risk assessments and risk management activities
• Identify and assess potential risks and recommend mitigation strategies
• Prepare and maintain quality reports, metrics, and key performance indicators (KPIs)
• Perform other duties, as needed

Qualifications:

• Bachelor's Degree in Life Sciences, Scientific, and/or a related field
• Experience in Quality Assurance or Quality Control within the Pharmaceutical, Biotechnology, or Rare Disease industry
• Strong knowledge of Regulatory requirements (FDA, EMA, ICH) and quality standards
• Proficiency in Document Control and Quality Management systems
• Great interpersonal skills
• Excellent communication skills (written and verbal)

Desired Skills:

• Certification in Quality Assurance or related field