QA Specialist Job at Tandym Group, Bedford, MA

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  • Tandym Group
  • Bedford, MA

Job Description

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

Job Tags

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