Job Requirement Detail
Company : Optghar
Req/job Title : Quality Systems Analyst-PLM
Job Ref No : 5762
Post Date : 10/29/2018
Country : USA
Job State/Province : California
Job City : Irwindale
PrimarySkill : QA / TESTING Jobs
Experience :
OtherSkill : 1. Someone with a Bachelor degree is a strong preference 2. 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. 3. 2-4 years of r
Subject : “Sr Quality Systems Analyst-PLM” with our Client, a top pharmaceutical company
Description :

Title:  Quality Systems Analyst-PLM

Location:  Irwindale, CA

Duration – 1 Year


Major duties and responsibilities:

Job Summary:

  1. Someone with a Bachelor degree is a strong preference
  2. 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.
  3. 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


·         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:


·         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