Quality Specialist – I (Assistant)

• Type: VMS
• Job #38612

Seeking a Quality Specialist for our client – a leading global pharmaceutical company who specializes in the development and manufacturing a variety of well-known pharmaceutical drugs, vaccines and animal-health products.

*1 year contract role. Hybrid, onsite 2-3x a week.

Duties:

• Direct support for batch documentation review ensuring our clinical supplies are in compliance with current GMP regulations and regulatory filing submissions.
• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable.
• Coordinate and/or support the preparation of procedures, processes and quality improvements.
• Assists in the coordination of significant quality events including fact-finding, investigation support, and coordination of clinical quarantine and recovery actions.
• Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
• Providing on-the-floor support of operational and technical issues; providing immediate responses 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 yield, 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.

Qualifications:

• Minimum of two years’ post-degree experience in the Pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.
• In-depth working knowledge of current GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Basic understanding of the use and maintenance for Microsoft (MS) applications (such as MS Excel, Outlook, and/or MS Access).