Job Description

Quality Assurance Specialist (Hybrid)
The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via related disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes direct support for batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications.

Duties may include, but are not limited to, the following:

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 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 and our Company's Production System tools, both in problem solving and day-to-day operational activities.

Education:

• Bachelor's degree.

• Technical emphasis in an appropriate scientific or engineering field preferred.

Required Experience and Skills:

• Minimum of two years' experience in the Pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Proficiency in using Microsoft applications (such as Excel, Outlook, PowerPoint, and/or Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as stakeholder management and conflict resolution skills.

• Demonstrated teamwork skills and ability to work independently.

• Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred Experience and Skills:

• Familiarity with batch disposition (release) activities is strongly preferred; prior batch disposition experience is a plus.

• Prior experience reviewing and approving investigations, deviation management, and Corrective/Preventative Actions (CAPAs)

• Previous background in quality control, quality assurance, auditing, or regulatory affairs.

• Ability to independently manage multiple priorities and projects.

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

• Demonstrated analytical and problem-solving skills, knowledge of Lean Six Sigma and Project Management.

• Computer skills; knowledge and competency in Enterprise Resource Planning (ERP)/Manufacturing Execution Systems (MES), SAP and Veeva vault.

Current Employees apply