Senior QA Specialist for Incoming Materials

10 hours ago


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

Proclinical Staffing is seeking a highly skilled Senior QA Specialist for Incoming Materials to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of materials procured by our organization.

Key Responsibilities:
  • Conduct thorough review of documentation of incoming materials to ensure they meet quality standards and specifications.
  • Release materials in SAP and provide final quality decision.
  • Maintain accurate records and ensure all documentation meets ALCOA principle, is organized, and accessible for reference and auditing purposes.
  • Communicate effectively with QA suppliers' team regarding quality issues, non-conformances, and corrective actions related to incoming materials.
  • Participate on Root Cause Analysis (RCA), investigate root causes of quality issues or non-conforming materials, and implement corrective and preventive actions to prevent recurrence.
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 pharmaceutical industry.
  • Experience working with SAP's Quality Management (QM) modules or similar quality management software within an ERP system.
  • Familiarity with SAP's Materials Management for procurement and inventory management.

Proclinical Staffing is an equal opportunity employer. If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.



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