Test Lead overseeing testing activities to ensure software quality and mentoring team members. Collaborate with project stakeholders and recommend process improvements for testing efficiency.
About the role
- Senior QA Specialist leading quality assurance for client projects in a biopharmaceutical company. Driving compliance and facilitating client interactions to ensure effective quality systems.
Responsibilities
- Serves as QA facilitator for the Quality aspect of client projects.
- Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline.
- Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues.
- Supports Batch disposition, fully executing the disposition process as needed.
- Supports audit / inspection readiness of the site.
- Works with Global Compliance to support Client Audits
Requirements
- BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries
- Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements.
- Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role
- Ability to communicate in customer-facing forums to progress issues and obtain positive results.
- Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365).
- Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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