Trusted IT Advisors
York Jobs of the Week: May 15th
May 19, 2017
Our mission is to provide creative, cutting-edge IT solutions to help companies achieve business, technology, and operational goals and objectives. We believe strongly in creating a true partnership approach with our clients and consultants that fosters a long-term, trust-based relationship.
Healthcare Compliance Auditor
Looking for someone, contract-to-hire, to perform FDA Compliance Audits. They will need to have medical device manufacturing auditing experience and/or experience with 13485 ISO Standards. Needs to be familiar with sterilization if possible. Also, needs to have impeccable technical writing skills as their deliverable will be to provide reports of their audits. In the interview process, they will be asked to provide an example of their writing. They also need to be extremely professional as they will be visiting suppliers’ sites for auditing purposes and representing the client. They will also be visiting other client facility sites for auditing purposes. They will be traveling up to 30% and it will be global travel. Highly prefer local candidates; however, will entertain out of state candidates. Initially they will need to be onsite, but once they ramp up some remote work will be ok. Manager would like to interview ASAP and have them start immediately. Looking to bring on 1-2 people.
The person hired for the position of Quality Compliance Auditor will schedule, conduct, and issue reports for comprehensive audits of drug and medical device product quality systems using Food and Drug Administration (FDA) and related industry standards as well as current industry practices. These audits will address compliance, suitability, and effectiveness of both the system as well as some technical aspects of the associated products.
The position will require occasional international travel to both internal locations and external supplier locations. Up to 30% global travel is required. Other requirements of this position may include periodically conducting training as well as participation in projects.
Primary Responsibilities include, but are not limited to, the following:
- Schedule, conduct, and report results of Quality Management System (QMS) audits
- Communicate summary of audit results to management team
- Lead short-term audit teams
- Bachelor's degree or higher in an Engineering or Science discipline from an accredited institution
- Minimum of three (3) years of combined experience in Quality and/or Manufacturing in a health care regulated industry
- Minimum of one (1) year experience performing audits of quality management systems
- Recent experience with auditing quality management systems of either device or drug development or manufacturing organizations
- Professional certification(s): American Society for Quality (ASQ: Biomedical Auditor (CBA) or Quality Auditor (CQA) and/or Exemplar Global Incorporate (formerly known as RABQSA) Quality Management (ISO 9001)
- Prior experience in auditing to Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or software design requirements
- Willingness and ability to travel frequently, may require several trips per month of differing durations
- Excellent verbal and written communication skills (extensive report writing is expected)
- Bi-lingual, English and Spanish or Chinese Mandarin
- Self-starter/self-directed that leads with high energy and passion
- Ability to work with all levels in an organization and across disciplines
- Ability to multi-task and handle large workloads under time constraints
- Microsoft Office proficient, SAP experience a plus
This job was posted on 5/15/2017. Click here to view the original posting.
Business Systems Analyst
Healthcare background is a MUST and would strongly prefer someone from the Franklin, TN area. This person will be sitting on the matrix engineering team. Looking for someone with experience in Rally, Jira, and Viso. Must have strong communication skills and the ability to work with offshore teams. Needs to have strong business operations understanding, as well as understanding custom software development process. Need to be able to do process modeling and business modeling.
What are the top 5-10 responsibilities for this position?
- Liaise between Business Subject Matter Experts, Business Analysts, Engineering teams, System Architects, and Project Management groups
- Analyze business requirements; demonstrate clear problem understanding and benefit of solution; model business operations; analyze and design solutions as part of software development life cycle
- Translate business needs into actionable documentation/specifications including use case scenarios, models, conceptual design diagrams, and user stories to support iterative development
- Advise and support Engineering team during development cycle
- Evaluate and present solutions objectively and facilitate conflict resolution
- Collaborate with architects on design and build/buy/integrate decisions
- Consult with key stakeholders on complex systems integration issues
What software tools/skills are needed to perform these daily responsibilities?
Microsoft Office, Visio, strong written and verbal communication, ability to understand complex business process and needs, and translate to technical requirements
What skills/attributes are a must have?
- Demonstrated success consulting with stakeholders on complex technical issues
- Previous experience conducting analysis for systems integration programs or data analysis
- 4+ years of experience conducting and facilitating requirements gathering and performing business systems analysis or equivalent business process analysis
- 4+ years of decomposing business requirements into user stories; and writing technical documentation to support solution delivery including business process improvement and workflow diagrams, business process and system integration models, and technical specifications
- Experience working within the Software Development Life Cycle
- Experience working in an Agile/SCRUM environment
- Previous proven experience using written and verbal communication skills with various levels of management, stakeholders, and subject matter experts
What skills/attributes are nice to have?
- MS Office, MS Visio
- Experience working with offshore teams
- Knowledge of Revenue Cycle Management concepts
- Healthcare Industry experience is a plus
This position was posted on 5/17/2017. Click here to view the original listing.
Our direct end client in St. Paul, MN is looking for a Deployment Lead for a 12+ month project.
We're looking for a strong project/program manager that has managed several deployments in the past. Someone that maybe specializes in deployments, but also needs to be slightly technical so that they can work with label designers, technical team, and the legacy team in order to ensure the deployment goes well.
The person hired for the position of Global Labeling Deployment Leader will analyze current local labeling solutions to identify and implement the best global solutions across different ERP platforms. The role will work closely with site labeling leads, business group label leads, logistic execution, production execution, and several other IT and business teams. The person hired in this position must have the ability to work in a highly cross-functional team aligning processes and designs for a highly complex organization.
Primary Responsibilities include, but are not limited to, the following:
- Plan, execute and deliver deployment of labeling solutions including SAP-integrated Loftware, Loftware web access, and legacy labeling applications as required
- Define and implement repeatable deployment processes for different project types
- Communicate and provide coaching of the Labeling Solution deployment strategy to the business and site representatives
- Coordinate Labeling Solution deployment activity and schedules with Business Transformation, the business, and site representatives
- Coordinate post-deployment hand-off activity with Labeling Support and SAP Run organizations
- Lead deployment-driven label design activity to ensure label templates are aligned with business and site requirements
- Communicate business and site labeling requirements to Labeling Build team
- Determine priorities and assign resources to labeling deployment activities
- Provide work direction to deployment label design and business analysis team members
- Bachelor's degree or higher from an accredited university
- Minimum of 3 years of experience working within a cross functional team
- Experience with on-demand labeling and current labeling platforms such as CodeSoft, Bartender, Loftware
- Minimum of 3 years of project management or equivalent experience
- Skills include strong communication, project management, and handling multiple priorities
- Experience in leading cross-functional teams
- Knowledge of SAP landscape
This job was posted on 5/18/2017. Click here to view the original posting.
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Posted By: Jaclyn Roman