Title: Quality Systems Analyst-PLM
Location: Irwindale, CA
Duration – 1 Year
Major
duties and responsibilities:
Job Summary:
- Someone
with a Bachelor degree is a strong preference
- Open
to candidates who are about to finish school (for Bachelor degree) with
some computer experience, who are willing to learn new skills and obtain
work experience too.
- 2-4
years of relevant work experience is ideal
Quality Systems Analyst-PLM position is responsible for the analysis, support, and business risk
assessment of Product Lifecycle Management and Quality Systems
software. This function interfaces with multiple business units within Ethicon
and CSS family of companies. Will be considered a subject matter expert
(SME) on Quality Systems software and how they support the business processes.
Will be tasked to work on small to moderately complex problems and projects.
Regularly partner with IT and Computer Software Validation (CSV) teams to
support the business’ strategic objectives, prioritizes initiatives, and
identifies opportunities for applying current technologies to add business
value; ensure compliance with the Franchise’s Quality System policies and
procedures and applicable external requirements and standards.
Major Duties and Responsibilities: 60%:
· Working
with other functional groups, including R&D and Operations in ensuring
the availability of Quality Systems software
· Manage, analyze, and update, quality systems software
used by Ethicon and CSS family of companies.
· Perform basic configuration changes
· Manage and support administrative changes required in
Quality Systems software and system interfaces
· Collaborate with IT support team on a frequent basis to
address any software issues / project discussions.
· Provide directives to IT support team in resolving
end-user support issues
· Perform periodic users review and collaborate with IT
support team to deactivate user accounts
· Collaborate
with Information Technology, CSV, and the Business Owner in evaluating and
reviewing system-related enhancements and fixes to the Quality Systems
software
· Make recommendations to supervisor to improve
department’s operating efficiency
· Periodically
review standard operating procedures and work instructions relevant to the use
of the Quality Systems software and revise as necessary;
· Provide instructor-led training to end-users on the
new/updated processes in the Quality Systems software
· Author
and support in reviewing validation documentation deliverables relevant to
Quality Systems software prior to production deployment
· Train testers in performing validation tests (e.g. UAT);
may be asked to execute validation tests from time to time
· Ensure a
high degree of Inspection Readiness for Systems in the business
portfolio--minimize the risk of inspection observations to
Business systems/infrastructure.
· Support
the business in audits, review audit non-conformity action plans and closure of
internal audit findings related to the Quality Systems software.
· Recommends issue resolution to impacted functions for
significant capability and compliance issues
30%:
· Builds
and maintains trusting, collaborative relationships and partnerships with
internal and external stakeholders (e.g. project leads, validation technicians,
management) which help accomplish key business objectives, and helps
others to do the same
· Communicates business-related issues and/or opportunities
to next management level
· Ensures
personal and Company compliance with all Federal, State, local and Company
regulations, policies, and procedures
Quality Systems Analyst-PLM Job
Description and Requirements
· Ensure timely reports of status updates, metrics and time
sheets as required by the department/Supervisor.
· Ensure timely completion of assigned training and expense
reports.
· Ensure timely completion of assigned CAPAs, audit
observations, and non-conformances
· Performs other duties assigned as needed
Job Requirements:
Required:
· 2-4 years
of related experience and a bachelor’s degree (with strong preference given to
a Business, Science, or Engineering major)
· Proficiency in Microsoft Office Applications, Adobe
Acrobat, and knowledge of database-driven applications
· Knowledge of GDP, and FDA and ISO standards.
· Excellent communications and interpersonal skills,
including with multiple levels of management
· Clear and effective communicator (presentation, technical
writing, verbal)
· Be detail-oriented and able to work in a team-based
environment
· Excellent time-management and problem-solving skills
· Ability to work in a fast-paced, multi-tasking
environment with rapidly shifting priorities
· Ability to quickly adapt and navigate various technology
and computer software
· Experience in authoring procedures and work instructions
in a regulated environment.
· Experience and/or understanding of project management
· Understanding and knowledge of software development
lifecycle methodology
· Able to lead and/or attend meetings, whether in person or
teleconference
Preferred/Nice to Have:
· Experience
in Quality Systems processes (e.g. change, document management, CAPA,
Nonconformances, internal audit)
· Experience with Quality Systems (e.g. EtQ, PLM) and ERP
software
· Experience working in various functions of a corporate
organization and cross-functional experience
· Experience working in product development and/or
manufacturing-based organization
· Experience with testing management software (e.g. HP ALM)
· Experience with system/software development methodology
(e.g. SDLC/Agile) from concept to production
· Experience with computer system validation support (e.g.
executing User Acceptance Test Scripts)
· Experience with supporting internal audits and inspections
by regulatory authorities