Primarily responsible for quality assignments related to batch records, quality approvals, exception reports, metrics, and other documentation.

Responsibilities:

 Review/approve/release batch record packets and associated documentation

 Provide quality approvals of materials in the materials management system as defined by procedures

 Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements

 Review/approve clinical documentation and specifications, as applicable

 Write/review/approve policies/processes/procedures and related documents

 Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance

 Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues

 Generate, analyze and report quality metrics to management

 Lead/participate with support groups in developing/prioritizing QA activity timelines

 Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements

• Qualifications:

   Bachelor's degree or equivalent experience is required, preferably in life sciences or engineering

   6+ years’ experience in Quality Assurance or related field, preferred healthcare industry or experience in quality function

   Strong understanding of US and international regulations for quality systems and compliance

   Experience in coordination and planning of complex activities

   Proven organizational skills

   Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities

   Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues

   Ability to identify and resolve complex problems through effective use of technical and interpersonal skills

   Capable of clearly presenting and justifying quality requirements throughout all levels of management

   Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)