Senior Quality Assurance Scientist

Position Summary:

Our client is seeking an experienced and motivated individual to work closely with their development and manufacturing teams on product and process improvement and new product development. Reporting to the Director of Quality, the Senior Quality Assurance scientist will prepare, implement, conduct, monitor, and report on product compliance, reliability, and process quality programs. The role requires experience in a biotech, pharm, and/or medical device environment.

Responsibilities:

• Consults with development and manufacturing departments on scientific processes, product and process improvement, and new product development
• Prepares and issues assigned quality reports
• Provides input to specification and product definitions
• Collaborate with subject matter experts across multiple functions to ensure the quality and technical accuracy of content
• Self-driven, takes ownership, and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives
• Review and/or comment on the technical content of intra and interdepartmental reports
• Determines and/or recommends direction taken on the technical product or manufacturing issues
• Assures compliant and complete product documentation, inclusive of Master Batch Records and that support successful and compliant product approval and release
• Ability to influence cross-functionally and within a large cross-site manufacturing operation
• Ensures positive, productive, and proactive relationships with a range of key internal stakeholders
• Provides design review and risk assessment support
• Assures newly developed products are successfully transferred into the manufacturing environment
• Adheres to policies and procedures. Exercises independent judgment in quality assurance-related activities

Requirements and Qualifications:

• Excellent oral and written communication skills
• BS Degree in Chemistry, Quality, or related field with 5+ years' experience or Master's degree in field with 3+ years' experience or Doctoral degree in field with 0-2 years' experience in development or manufacturing quality in research use, medical device, IVD or related field
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy
• Working knowledge of U.S. and international regulations (QSR, ISO, GLP, cGMP)
• Applies analytical skills and independent judgment to develop innovative, practical, and consistent solutions to a wide range of complex problems
• Effective team collaboration, influencing, and facilitation skills
• Full knowledge of industry standards and Good Lab Practices
• Experience working under pressure, prioritizing, and multitasking quality issues in real-time
• Uses complete understanding and wide application of technical concepts, standards,and practices in chosen field and is expanding knowledge or related disciplines