Scientific Information Management Consultancy

Database

Before joining Scimcon, Cass was at Genzyme working in QA. Prior to that she was in lab management for and quality control for pharma companies and the Dubai Equine Hospital.

Consultant – 5 years
Preparing URS documentation for all projects. Validation and acceptance testing: planning, creating and executing of validation plans and test protocols. Guest speaker at international LIMS conferences

In the lab – 8 years
Clinical laboratory manager, Therapeutic quality control analyst, Quality assurance auditor

Cassandra Harris, Quality Lead

 “I am a perfectionist, but also a pragmatist. My aim is to get everything perfect enough.”

The challenge of working in QA for clients is often less in the systems, than the people. It’s Getting to grips with the dynamics of a company – and its politics – is frequently just as vital as understanding the company’s QA workflows.

“Quality people are often seen as the bête noir of many scientists.”

As an outsider it can be easier to succeed in QA as you’re not treading on anyone’s toes, as you have a specific, project-focused goal that everyone can get behind. You still have to be determined, but you are seen as someone who’s working with the best of motives and the labs best interests at heart.

“Diplomacy is a key skill – clients are looking for guidance and we have to tactfully find a way to encourage change where its needed.”

The difficulty in achieving a successful audit is also in striking the right balance. Obviously there are some things you know you’ve got to put right, like highlighting inappropriate work ethics or varying abilities to document things. But at other times you can make a judgement on how far it’s necessary to go. We tend to take a risk-based approach to client problems – you have to focus on what’s core to the business. It’s not that you have to do everything regulations suggest, but like it or not, you do have to be detailed enough.

We are all conscientious – professionals – that’s part of the Scimcon distinction. And we definitely make things happen. We feed off each other and we’re inspired by clients too. It’s a great feeling when you’re working with people who you know are on top of their game.



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