Quality Associate

Key Responsibilities

• Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Substance, Drug Product and Packaging operations on targeted/prioritized activities.
• Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.)
• Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply.
• Consolidation and issuance of key performance metrics per Process Team
• Provide back-up support for Process Team Leads where necessary (e.g. holidays)
• Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.
• Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.
• Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).
• There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task.
• This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.

Experience & Skills

Minimum requirement of 5 years' experience within an Operations and regulated environment.

Relevant 3rd level qualification.

Required skills needed to accomplish the responsibilities/essential functions include:

• Will have a working understanding of ERP systems (e.g. SAP)
• Will have a good working understanding of the processes/unit operations assigned to the team.
• Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
• Experience in lean/six sigma/continuous improvement tools and techniques.
• Excellent written and verbal communication skills.
• A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.
• Ability to work independently.