Open Positions

SharePoint Developer (Multiple Positions)
We are looking for an experienced SharePoint Developer The successful applicant will form part of a team responsible for the development and maintenance of an industry specific solution using SharePoint. This will involve all phases of the design, development and maintenance of enterprise solutions. The role will include developing in C# and .NET and working with SharePoint 2016 and Office 365 and other technologies. In this position you will be joining the development team to create solutions in a timely manner.
Location: Bengaluru, India
Duties and Responsibilities
  • Investigating, analyzing and documenting requirements.
  • Designing, developing and maintaining key software components.
  • Implementing SharePoint based workflows.
  • Designing, developing and managing site content and capabilities.
  • Testing all software developments and resolving any issues.
  • Working with project managers to provide accurate development estimates.
Quality Assurance Analyst
We are looking for a junior to mid-level experienced Quality Assurance / Validation Analyst who has experience in working in a GxP regulated environment. Candidates to have at least 3 years of experience with Computer Systems Validation or Quality Assurance in Pharmaceutical/regulated GxP areas.
Location: Marlborough, MA
Duties and Responsibilities
  • Assist in maintaining the processes needed for Quality Systems to function effectively.
  • Drive established QA practices and methodology.
  • Collaborate with QA manager and Quality Control teams to develop, implement and improve innovative systems that are FDA compliant (21CFR Part11).
  • Provide compliance oversight over execution of company policies and procedures.
  • Support customer audits and assist in conducting internal audits and periodic reviews.
  • Assist in authoring and reviewing Standard Operating Procedures and Work Instructions.
  • Work closely with testing team to support and review product release documentation of various software products developed by ACUTA.
  • Responsible for defining and measuring customer and product data Service Level Agreements (SLAs) and Data Quality Metrics.
  • Promote quality achievement and performance improvement throughout the organization.
  • Assume responsibility for all systems related to: Training (Learning Management System), Change control, Records requirements, Issues/CAPAs, and Product Complaints.
  • Report periodically to manager on performance of Quality Systems and improvement needs.
  • Assist and/or perform internal and external audits. Report results and assure that corrective actions are completed in a timely fashion.
  • Proactively participate in identifying and implementing process improvements.
  • Review and approve all change orders, deviations, incident reports and CAPAs.
  • Collaborate with Product Development, IT, Testing, and Client Support to identify quality issues and develop and implement action plans to resolve all issues.
  • Maintain all training files and communicate employee training status to all departments.
Minimum Requirements
  • Bachelor's degree in computer science or related technical discipline.
  • 3+ years Quality Assurance or Computer System Validation experience in preferably in Pharmaceutical Industry.
  • Experience with authoring/reviewing and approving software development life cycle deliverables.
  • Understanding of 21CFR Part 11 and GxP regulations.
  • Experience executing and coordinating integration, system, regression and user-acceptance testing.
  • Knowledge of Learning Management Systems, Document Management Systems, Bug Tracking Systems, and Audits is a plus.
Business Analyst
The Business Analyst is responsible for helping ACUTA implement technology solutions in a cost-effective way by providing detailed requirements for ACUTA software products. The Business Analyst will ensuring effective analysis of the requirements to identify the impacts for development and testing teams. The Business Analyst will provide direction to the Product Development, Quality Control, and Management teams during the development iterations, ensuring that product related questions are answered promptly. In addition, the Business Analyst will support the Product Manager in the identification of new requirements, requirement prioritization, prototype design, and support of all ACUTA products and supporting tools.
Location: Marlborough, MA or Bensalem, PA or UK (Remote)
Duties and Responsibilities
  • Translate User Requirements into Functional and Technical Requirements to be implemented by Product Development and Quality Control teams.
  • Business analysis of requirement updates – identifying technical and business impacts to ensure effective decision making.
  • Support the development and documentation of user scenarios for new product features.
  • Assist with the maintenance of the User Requirement Specification (URS) and the URS Trace Matrix.
  • Contribute to the prioritization of requirements based on both external and internal feedback.
  • Provide guidance and support to product managers on developing new products and managing the lifecycle of existing products.
  • Develop & implement processes to drive collaboration between, quality and product development.
  • Identify and track requirements for test script updates that are initiated by requirement changes.
  • Where necessary, manage the creation of conceptual prototypes and mock-ups.
  • Help facilitate the implementation and maintenance of a more Agile development process, including acting as Scrummaster in the daily stand-ups and assisting with the maintenance of an iteration plan.
Other Responsibilities Depending upon the skills and experience of the individual Business Analyst, additional responsibilities may include:
  • Ownership of the User interface design, ensuring consistency of technology and implementation across modules.
  • Prototype development as needed with key teams.
  • Ownership of the ARIM database: identifying the impact of updates and ensuing effective implementation and migration.
  • Project Management responsibilities to ensure the effective, on-time, delivery of ACUTA product.
  • Other duties as assigned
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Proven experience of eliciting and drafting Use Cases and Business/User Requirements.
  • Capable of translating high level business requirements into detailed functional requirement documentation. This would include mock-ups, process diagrams, entity details and database table updates.
  • Strong business analysis skills – to ensure that the impacts of a product update are understood across the product and for both development and QC.
  • Effective written and verbal communication skills, to ensure a good day to day relationship is achieved with development and QC.
  • Ability to work with different people across a team effectively.
  • Solid knowledge of the processes associated with Regulatory Affairs and/or Regulatory Operations is a distinct advantage.
  • Experience with Regulatory Information Management oriented products and services.
  • Proven track record of Regulatory Affairs Operations domain knowledge with knowledge of eCTD and non-eCTD submissions.
  • Bachelor's degree required (MBA or other Masters preferred) and 6-8 years of experience related to the business analysis skill set.
  • Experience with modeling techniques and methods and business case development.
  • Ability to work as a single contributor with potential growth for potential leadership role.
  • Project Management experience in an Agile development environment would be an experience.
Product Documentation Specialist
The Product Documentation Specialist is responsible for supporting ACUTA to implement technology solutions in a cost-effective way by creating a variety of supporting documentation. The primary role will be to support the release of new product by providing detailed documentation that describes the nature and impact of new product updates. This documentation will be the basis of updates to Release Notes, User Manuals, Operational Qualification(OQ) Scripts and Training Material. To produce this documentation, the Product Documentation Specialist will need to work closely with many departments including Product Management, Product Development and Quality Assurance. In addition, the Product Documentation Specialist will support the Product Manager with a variety of tasks associated with the effective delivery of the ARIM product.
Location: Bangalore, India
Duties and Responsibilities
  • Tracking the key updates being implemented in ongoing development. Working closely with Development and QA to ensure all updates are identified.
  • Documenting all changes that are included in each new release, prior to the release. This includes detail descriptions of user interface and process changes, and their impacts on the user.
  • Contributing to the creation of PowerPoint presentations, to ensure that reveals of updated product are effective.
  • Provide Release Note entries for all product updates included in the release.
  • Working with Development, Quality Assurance, Client Services and other departments to assist with the creation and review of product documentation created for new releases. Including User Manuals, OQ Scripts and Training Material.
  • Reviewing and enhancing Feature Requirements documents created by Product Management.
  • Provide guidance and support to product managers on developing new products and manaing the lifecycle of existing products.
  • Develop & implement processes to drive collaboration between, quality and product development.
  • Identify and track requirements for test script updates that are initiated by requirement changes.
  • Where necessary, manage the creation of conceptual prototypes and mock-ups.
  • Help facilitate the implementation and maintenance of a more Agile development process, including acting as Scrummaster in the daily stand-ups and assisting with the maintenance of an iteration plan.
Other Responsibilities Depending upon the skills, experience and ambition of the individual, additional responsibilities may include some of the following. It should be noted that the ideal candidate will be keen to progress into a Business Analyst role:
  • Support the development and documentation of user stories for new product features.
  • Assist with the maintenance of the User Requirement Specification (URS) and the URS Trace Matrix.
  • Where necessary, assist with the creation of conceptual prototypes and mock-ups.
  • Manage the release process for patches and hot fixes.
Qualifications and Experience To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Bachelor's degree required and at least two years appropriate experience of eliciting and drafting technical documentation, preferably documenting software user manuals or guides.
  • Excellent English – both written and speaking.
  • Good communications skills are needed as the Product Documentation Specialist will need to discuss and understand product updates at a user and technical level. Ability to work with different people across a team effectively.
  • Advanced use of Microsoft Word is essential and Acrobat Professional preferred.
  • The ideal candidate will be keen to progress into a Business Analyst role.
  • Any domain knowledge of Regulatory Affairs, eCTD Publishing and associated subjects will be an advantage.

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