Specialist, Quality Assurance - Hybrid

Job Description

This position reports to the Sr. Specialist, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) 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 in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. 

Primary 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. 

• Completing projects to improve the performance of our processes, including continuous process improvements, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

• Assists in the coordination of significant quality events including fact finding, investigation support

• Collaboration across IPT functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

• Actively using and championing the use of Lean Six Sigma and our company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.

Education Requirements:

• Bachelor's Degree or higher in engineering, science, or related discipline.

Required Experience and Skills:

• Minimum 2 years of experience in the pharmaceutical or equivalent industry, Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.

• Familiarity with batch disposition activities

• Strong problem-solving, and written and oral communication skills

• Ability to manage multiple priorities

• Demonstrated teamwork skills and ability to work independently

• Proficiency in the use and maintenance of Microsoft applications (Excel, Outlook, and/or MS Access, Teams)

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

Preferred Experience and Skills:

• Proven ability to work independently and collaborate effectively as part of a team.

• Strong organizational, interactive, and time management skills.

• Computer skills; knowledge and competency in ERP/MES, Trackwise, SAP

Required Skills:

Auditing, Auditing, Communication, Compliance Monitoring, Compliance Reporting, Continuous Process Improvement, Data Analysis, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, Lean Six Sigma (LSS), Legal Document Review, Medical Supply Management, Microsoft Applications, Policy Implementation, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Improvement, Quality Management, Quality Metrics, Regulatory Compliance, Six Sigma, Team-Building {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that