Quality Engineer supporting production processes using quality tools and statistics for meeting organizational quality objectives. Engaging in lean system maintenance and new product introductions.
About the role
- Quality Assurance Specialist ensuring compliance with regulations and quality in clinical supply chain for pharmaceutical company. Responsible for oversight of clinical supply materials and processes.
Responsibilities
- safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures
- provide independent assurance that delivers high quality data and clinical supplies
- Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations
- Coordinate and/or support the preparation of procedures, processes and quality improvements
- Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions
- Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
- Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations
- Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times
- Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
- Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities
Requirements
- Bachelor's degree with a concentration in a scientific-related discipline
- Minimum of 5 year's experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field
- Familiarity with batch disposition (release) activities
- Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs)
- Background in quality control, quality assurance, auditing or regulatory affairs
- In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access)
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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