Title: Project Support, Quality Systems

What are the top 3-5 skills, experience or education required for this position:

• Experience working with Quality Management Systems (e.g. TrackWise)
• Strong Microsoft Excel skills – ability to use spreadsheets and process large
• quantities of data
• Attention to detail, accuracy and consistency when performing tasks
• Good written and oral communication

Purpose:

• The Project Support, Quality Systems is responsible for performing a wide variety of project management and system administrative support services, ranging from complex to routine.
• The role will support the Quality Operations strategic direction to deliver a best in class Quality Management System.
• The role owner will be a key support to the Project managers and Project Team members by accepting and assuming responsibility for a number of key project activities.
• They will work collaboratively with both the Global and Local Teams throughout the duration of the project.

Responsibilities:

• List up to 10 responsibilities of the job including information regarding scope and accountability.
• Supporting the project team to facilitate delivery of the Quality Management System by bridging the gap between the project plan and the desired outputs for success
• Performing project management activities such as developing plans, preparing progress reports & holding personnel accountable to timelines.
• Establish and oversee a process to manage support transition from legacy system to Quality Management System
• Experience in developing UAT test cases, writing UAT scripts and executing UAT.
• Engaging in system administrative activities such as data cleansing & verification, setting up items in the system, UAT activities.
• Supporting the creation of work instructions & training content on system usage
• Supporting the project team to coordinate project activities that involve local sites
• Creation of presentations, reports and project related topics to ensure effective communication to stakeholders

Qualifications:

• List required and preferred qualifications (up to 10). Include education, skills and experience.
• Bachelor’s degree in one of the following disciplines: Science: Chemistry, Biology, Microbiology: Engineering: Pharmacy or other technical/scientific areas
• Minimum 3-5 years experience in quality assurance and/or quality process oversight
• Experience working within a Quality Management System.
• Proven ability to collaborate and partner across all levels of the organization
• Experience working in both team setting and independently. Works well with minimal manager guidance while able to manage own time effectively

Spotlight Call Notes –

• Global organization and has regional auditors throughout our team, within our team, is a group that organizes and plans all activities for our team.
• Looking for two candidates for our org is assisting with two large projects, integrating two new companies into Client as well as new system integration.
• Some experience within Pharma if possible.
• How to manage relationships with individuals asking for support, solid communication skills, being able to build rapport
• Prepping for audits, querying in the system and managing data in the systems, so attention to detail is important.
• Mistakes are hard to discover in systems so big – someone who is collaborative and adaptive to overall team dynamics to be able to accomplish projects as needed.
• Ideally, prefer to have them in Lake County - but looking for the best, right fit - first and foremost.
• Managing within systems and then manage within our team and across the network.

Data Management – is that the systems you are referring to?

• It is data management systems internally, Sole Track is used to manage and track audits and systems. We do queries and different actions to find data sets needed.
• Regulatory inspections – being able to find data; if asked a question, being able to find the most appropriate data to answer their questions
• We have our internal, Sparta System (internal system) for supplier management.

How much of the work is query and data management is this job – what percentage?

• It is a pretty significant part of the role.
• If we have them work on audit prep – a lot is pulling from the system to find the information for that supplier to assign the audit prep out to the sites.
• Most of what we do is linked to the system.
• We have two pieces – the standard part of the business, the audit side which we manage data within our systems.
• In addition, we are transferring data over from the other system to our system.
• Second project, which would also be supported in this role, is the integration of new company into Client, verifying data, bringing it over to Client, etc.
• Project Coordinator experience with data and data management.
• No scripting is needed for this role for UAT tasks.
• Overall QMS system experience is fine, does not have to be in specific systems we use.
• Trackwise specific experience is not required, but overall QMS experience, pharma exp and background would help to understand how to manage data and expectations.
• We can train to the specific systems.
• Open with candidate with AA and good experience, if does not have a BA degree.
• Really depends on experience.
• If the other background is not there.
• Data Analyst focus, fit for this type of role.
• Being able to run queries, pivot tables – as long as they are good with working with others and have the interpersonal, QMS background would be most important.
• Within the realm of QMS are there other systems that we can key into that would indicate they have this QMS; Supplier Quality, incoming Quality type words would lead to this type of individual. Not just quality systems, but also understanding suppliers and how to manage expectations.
• External Audit group experience is not required.
• BA discipline is open as long as they reflect the related and type of experience needed.
• That experience with QS background will help to enable them to be effective earlier on in training.
• As mentioned it is more the QMS, experience, quality experience, understanding data governance. Not as much an IT background –
• We don’t need direct IT experience, queries and finding data pieces are pretty simple. More just performing queries and pulling data into Excel for a lot of these projects. Nothing too complicated. But it is more understanding the data.
• The IT side is nothing complex.
• What is the minimum years’ experience would you like to see.
• Year’s of qualification would not disqualify someone – but is more of what the type of experience that they have.
• Some flex with scheduling.
• Keep it to people who can be onsite three days onsite, two offsite.
• It is much a team environment and working collaboratively within the team.
• What are other types of titles you would see for this role: Supplier Quality Management experience, Quality Project Implementation; QA Analyst, QA Specialist… Quality System QA; could be Compliance; Quality and Compliance

Job Type: Contract

Pay: $42.00 - $43.00 per hour

Expected hours: 40 per week

Benefits:

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• Quality Management System.: 4 years (Preferred)
• Pharma or biotech or medical device or healthcare industry: 4 years (Preferred)

Ability to Commute:

• North Chicago, IL 60064 (Preferred)

Work Location: In person