Senior Quality Assurance Specialist

4 days ago

Cambridge, Massachusetts, United States Proclinical Staffing Full time
Job Title: Incoming Materials, Senior QA Specialist

Proclinical is seeking an experienced Incoming Materials, Senior QA Specialist to join our team in Cambridge, MA.

Job Summary:

The Incoming Materials, Senior QA Specialist will play a critical role in ensuring the quality and compliance of materials procured by our organization. This position requires a strong attention to detail, excellent communication skills, and the ability to work collaboratively with cross-functional teams.

Key Responsibilities:
  • Conduct thorough reviews of documentation for incoming materials to ensure they meet quality standards and specifications.
  • Maintain accurate records and ensure all documentation meets ALCOA principles.
  • Communicate effectively with QA suppliers' team regarding quality issues, non-conformances, and corrective actions related to incoming materials.
  • Participate in Root Cause Analysis (RCA) to investigate quality issues or non-conforming materials and implement corrective and preventive actions.
  • Ensure compliance with relevant regulations, standards, and industry best practices pertaining to incoming material quality assurance.
  • Support the quality assurance team in developing and implementing quality assurance procedures, protocols, and standards for incoming materials.
Requirements:
  • 8+ years of industry experience (6+ years of QA experience) for a biopharma company.
  • Excellent attention to detail and accuracy in data collection and analysis.
  • Effective communication skills, both verbal and written, with the ability to interact confidently with internal stakeholders.
  • Analytical mindset with the ability to problem-solve and perform root cause analysis.
  • Bachelor's degree in a relevant field such as Quality Assurance, Chemistry, Biology, Engineering, or related discipline.
Preferred Qualifications:
  • Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements in the pharmaceutical industry.
  • Experience working with SAP's Quality Management (QM) modules or similar quality management software within an ERP system.
Work Environment:

The Incoming Materials, Senior QA Specialist will work onsite in Cambridge, MA. Collaboration with cross-functional teams, including procurement, manufacturing, quality assurance, and logistics, is common in this role. Strong interpersonal skills are essential for effective communication and collaboration with internal and external stakeholders.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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