Job summary

 

In this role, you will be responsible for supporting the IT team in all aspects of developing FDA compliant IT systems.  This includes working with business users and Subject Matter Experts (SME’s) to understand the end-to-end processes and document all aspects of Requirement, Design and Testing & Training phase in the SDLC. In order to excel at this position, you will need to have a strong understanding of processes, interpret them into functional requirements and formulate detailed test cases for each requirement.

 

 

Primary Duties and Responsibilities

 

·         Gathers requirements as epics/ user stories,   participate in design, development as needed and creates documentation necessary to support further development and use of the applications

·         Work with internal teams to obtain an in-depth understanding of the system, business processes and the documentation requirements for documents

·         Produce high-quality documentation (e.g. Process Flow charts, user stories, FRS, Test Plan, Test Cases, Test Scripts, Summary Reports, Training Manuals etc) that meets applicable standards and is appropriate for its intended audience

·         Ensure backlogs are updated, prioritized regularly and are resolved in a timely manner while adhering to Prolacta SOPs and change control procedures.

·         Run daily, weekly and monthly agile rituals as required efficiently and diligently

·         Remove impediments as required

·         Lead communication between the business teams, technology and other support teams.

·         Recommend relevant user requests by critically evaluating information gathered from multiple sources, reconcile conflicts and decompose high-level information into details

·         Document and understand current as-is processes, collaborate with SMEs to design desired process, performs detailed gap analysis  and recommend business process improvements

·         Translates software functions/features into process driven user friendly materials to support implementation and training of variety of applications

·         Reviews and defines project requirements to ensure they are in line with business objectives

·         Lead small projects independently as a lead analyst

 

Job Requirements and Qualifications

·         Proven working experience in technical writing of software documentation (3 -5 years)

·         Prior experience in FDA regulated and/or Biologic companies desired (3-5 years)

·         Proven experience in providing production support for enterprise systems (from triaging to closing tickets while producing appropriate change control documentation)

·         Ability to quickly grasp complex concepts and make them easily understandable using text and visual aids

·         Very strong oral and written communication skills required.

·         Strong working knowledge of Microsoft Office including Visio

·         Good understanding of SDLC and software development

·         Understands validation concepts in order to produce documentation for validated systems

·         Good skills and knowledge of facilitation, continuous improvement, empowerment, transparency and servant leadership, Knowledge of Agile approaches – Kanban, Scrum etc

·         Experience running Scrum with JIRA,  Knowledge and experience with Agile techniques such as  Automated Testing, User Stories, Continuous Integration etc. preferable

·         Strong quantitative, analytical and problem solving skills.

·         University degree in Computer Science, Engineering or equivalent preferred

Other Knowledge, Skills and Abilities

 

Work Environment (Location, travel, shift, on-call, etc.)

 

Physical Requirements

 

a.    Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Stand

 

x

 

 

Walk

 

x

 

 

Sit

 

x

 

 

Talk or hear

 

 

 

x

Use hands to finger, handle or feel

 

x

 

 

Climb or balance

x

 

 

 

Stoop, Kneel, crouch or crawl

x

 

 

 

Reach with hands and arms

x

 

 

 

Taste or smell

x

 

 

 

 

b.    Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Up to 10 pounds

 

x

 

 

Up to 25 pounds

 

x

 

 

Up to 50 pounds

x

 

 

 

Up to 100 pounds

x

 

 

 

More than 100 pounds

x

 

 

 

 

 

Direct Reports