Quality Systems Business Analyst Jobs

Identifies issues and reports them to appropriate management attention immediately

Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development

Capability of understanding requirements of LIMS builds

Good judgment and correct decision making based on Pfizer procedures, PQSs, technical experience; and industry guidance/regulatory regulations

Effective written and verbal communication and interpersonal skills

Interface with and represents QO in cross-departmental and cross-site meetings, manage working area and projects/changes to accomplish change activities/project deliverables

Strong written and verbal communication skills are required to interact with diverse stakeholders.

Basic knowledge of Transmission and Distribution equipment and systems

Prefer experience with GIS, including ESRI SDE, shapefiles, and spatial indexes.

Excellent written and verbal communication skills.

Licenses, Certifications, Bonding, and/or Testing Required:

Develop and document processes with other functional data owners to support ongoing maintenance and data integrity.

Facilitating meetings, workshops, process diagramming sessions, requirement elicitation meetings, and requirement/test criteria walkthroughs.

We promote a diverse and inclusive workplace that respects the cultures, life experiences and traditions of our associates and the community

We offer a whole person approach to your health and well-being including financial resources and an Employee Assistance Program

Learn more about our associate benefits and perks focused on you

FMLI Level 1 industry certification expected within one year

Flexible work arrangements including remote, traditional and hybrid

Bachelor's degree in a relevant field such as Quality Management, Life Sciences, Engineering, or equivalent experience.

Proven experience in quality systems management, audits, and regulatory compliance, preferably in the life science SaaS industry.

Certifications in quality management or regulatory affairs (e.g., ASQ, RAPS) are a plus.

Document Control and Record Management:

Implement effective record management practices to maintain accurate and readily accessible records of quality-related activities.

Provide training to employees on quality system procedures, regulations, and compliance requirements.

Provide change request (enhancement management).

Participate in requirements gathering sessions with program and IT personnel.

Formulate and define system requirements, scope, and objectives.

Provide support to the development team for business requirement issues.

Maintain up-to-date knowledge of information technology "best practices" and procedures.

Business Analyst or related experience. (10 yrs of exp)

Basic knowledge of requirements management methodology

Basic knowledge of project management principles and methodology

Current knowledge of the Software Development Life Cycle (SDLC) and agile management principles

Bachelor's Degree or equivalent combination of education and work experience

Basic knowledge of terminology, function and fundamental capabilities of common computer, software, information and communication technology devices, components, and concepts

Utilize effective written and oral communication skills to share information

Partner with Ops / ERP system management team to ensure lot traceability capability

MANAGER: Quality Management System Director

Ensure systems maintain compliance with internal/ external requirements through data-driven oversight

Analyze underlying system issues and identify/define alternatives, assess feasibility and manage implementation of recommended solution

7 - 9 years System/IT/Configuration and administrative support experience in an FDA regulatory industry preferably in a Quality and Operations function

Strong organizational and communication skills with the ability to clearly explain and visualize processes and workflows.

Required Education, Experience, & Skills

Presenting alternatives for requirements and solution design and suggest improvements in business processes.

5 + years’ experience in an Oracle manufacturing environment

Demonstrated ability to configure application environments based on customer requirements.

This position is 100% remote

Providing day to day operational support of the TipQA system in coordination with the other members of the team

Two (2) years administrative experience with document management systems (such as eNovia) in a private, public, government or military environment

Quality Management Systems Analyst (Remote, MN)

Managing multiple systems used to support the Consumer Health Care Quality Management System (QMS)

Leading and administering document management systems

Skills include strong verbal and written communication skills and able to self-manage and consistently utilize good judgement in the auditing process

Three (3) years of quality systems experience in a private, public, government or military environment

Work with internal and external customers to interpret business requirements and produce functional specifications.

Assess customer requirements and construct test plans/scripts to ensure they are met.

Excellent verbal, written and interpersonal communication skills.

Love of learning with strong problem solving and critical thinking skills.

Experience working part of an agile development team.

Experience with Atlassian’s Jira and Confluence toolset along with SaaS solutions preferred.

Partner with business analysts and project managers to ensure requirements are documented, understood, covered by tests, and accurately tested.

Manage the business requirements process - 50%

Gather and document business requirements and User Interface and Reporting specifications and design.

Develop, publish, and implement use cases and technical requirements ((performance, scalability, security and usability) as required.

Document and evaluate test results and defects, track and manage defects and work with Development team and business to troubleshoot issues.

Establish and maintain traceability of requirements through test plans and cases.

Gain real-world experience and business knowledge working with a variety of clients across multiple industries

Grow your professional skills as you pursue a development path towards the Delivery Manager role

Minimum of 3-4 years of professional experience working in a Business Analyst role on an Agile software development team.

Strong communication skills to share user story acceptance criteria and test case results with technology-focused team members

Voluntary Benefits including; Accident, Critical Illness, and Medical Bridge Options

Here are just some of the things that we can offer you:

Experience with escalated/supervisor related customer calls/concerns

EOE/Minorities/Females/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity.

About TD Bank, America's Most Convenient Bank®

Must be eligible for employment under regulatory standards applicable to the position.

9:00am - 6:00pm - Monday - Friday

4600 Touchton Road, Building 200, Suite 400, Greenville Campus Building B - 200 Carolina Point Parkway

Collaboration and influence management skills to partner effectively across functions and operating units

Support the development and management of Supplier Quality Agreements.

Planning skills, previous project leadership experience preferred

Benefits on offer for this contract position:

Maintain and optimize standard supplier selection and qualification tools and processes for these suppliers

A minimum of 3 years of related experience

Experience using JIRA or other project management software.

Work with the Engineering Manager, Architects, and Software Engineers to design solutions that satisfy approved business requirements.

Project Manager or SCRUM certifications are a plus

Maintain a backlog of requirements, and prioritize based on current business and project priorities.

Participate in product design reviews to provide input on functional requirements, dependencies, or potential issues.

Bachelor’s degree or equivalent experience.

Experience using JIRA or other project management software.

Work with the Engineering Manager, Architects, and Software Engineers to design solutions that satisfy approved business requirements.

Project Manager or SCRUM certifications are a plus

Maintain a backlog of requirements, and prioritize based on current business and project priorities.

Participate in product design reviews to provide input on functional requirements, dependencies, or potential issues.

Bachelor’s degree or equivalent experience.

Quality Systems within the Pharma industry (e.g. Quality Event Management Systems, Laboratory Systems, Complaint Handling, Training any combination)

Experience facilitating requirements/stories using Agile Tools such as JIRA and Confluence

Extensive Background in Business Analysis / Requirements Gathering / Requirements Shaping and/or Development

Ability to capture requirements from business SMEs and effectively translate to development/technology team

Personality and experience collaborating in matrixed environment

Hands-on experience working in large corporate framework