Open Positions

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.
SW Engineer-Backend

Location: Bangalore/Kochi

Duties and Responsibilities
  • Working experience in Asp.Net Web Applications
  • Experience in developing REST APIs using Dotnet technologies.
  • Exposure to .NET applications using Visual Studio 2015 or later.
  • Experience with Azure Cloud based applications using Dotnet.
  • Good experience with NoSQL Document database such as MongoDB.
  • Experience with any Graph database is a plus

General
  • Knowledge and good awareness of SDLC lifecycle
  • Knowledge in various software design patterns
  • Experience or knowledge in Life sciences domain is a plus
  • Strong understanding of object-oriented programming
  • Knowledge in source code versioning tools such as TFS or Git or any others.
SW Engineer-Frontend

Location: Bangalore/Kochi

Duties and Responsibilities
  • Experience in Html, CSS, JavaScript, Typescript
  • Experience in developing SPA using Angular
  • Knowledge in angular-cli
  • Experience in working with NPM packages
  • Knowledge in CSS preprocessors
  • Experience in writing unit test cases for angular applications.
  • Experience in working with developer tools such as Chrome developer tools.
SW Engineer-DB

Location:Bangalore/Kochi

Duties and Responsibilities
  • Experience with NoSQL required, experience with MongoDB highly preferred
  • Experience with developing backend microservices using Node.js
  • Experience developing front-end web user interfaces with AngularJS is required
  • Experience with Test-Driven Development using automated testing frameworks
  • Ability to work with and coordinate with other developers
  • Experience with version control tools, such as Git
Test Engineers

Location:Bangalore/Kochi

Duties and Responsibilities
  • Unit/Functional /Integration test design (not writing but the understanding)
  • Testing automation
  • Continuous integration
  • Manual Testing
  • Test Script Development
Sr. Manager/Ass. Director Software Development

Location: Marlborough, MA

Duties and Responsibilities
  • Manage off-shore development teams in day-to-day delivery activities and Agile SDLC, working closely to understand the requirements and the outputs the team is producing.
  • Work closely with product owners and teams to lead feature implementation
  • Perform code reviews on deliverables from both staff augmentation development teams and third party product vendors.
  • Perform initial acceptance and ad-hoc functional testing of new features.
  • Work with solutions managers and technical project managers to plan and deliver solutions.
  • Collaborate with Solutions Architects on high level design, with a focus on cross-program goals and achievable paths to production.
  • Refine high level designs into lower level, actionable technical specifications.
  • Collaborate UI designers and team members to develop a cohesive user interface for new features.
  • Monitor and review the development of specific features including software engineering, QA, and documentation.
  • Balance strategic with tactical thinking and support business onboarding and adoption.
  • Contribute to standards and best practices around development processes, coding, and peer reviews.
  • Optimize existing systems to improve performance and scalability through service/application tuning and code refactoring.
  • Fully and properly test code to ensure the highest levels of reliability and maintainability.
  • Research and recommend software solutions and tools that help fix inefficiencies in the development process, team collaboration, etc.
  • Help lead and drive development operations initiatives.
  • Resolves customer complaints and responds to suggestions for improvements and enhancements. Participates in the development of software user manuals
Domain Expert

Location: Marlborough, MA

Duties and Responsibilities
  • Develop a clear and concise product vision & strategy
  • Develop a roadmap that is strategically aligned and demonstrates support for the vision & strategy
  • Responsible for working with Design team to develop concept prototypes. Furthermore, working with customers to validate concepts
  • Responsible for working with development team to insure implementation is sufficient to achieve the acceptance criteria
  • Resolve problems with products, working across teams
  • Review documentation at every phase of product life cycle, including metrics around consumer response
  • Provide consultation services related to Regulatory Information Management and standards.
  • Provide subject matter expertise on the systems including: specifications, use cases, and user requirements to the product development team
  • Liaison with Standards Development Organizations
  • Responsible for developing strong partnerships across the organization
  • Conduct trends and opportunities analysis and market research to guide decisions
  • Support sales and marketing efforts, including pre- and post- sales consulting work
  • Knowledge of XEVMPD and IDMP
Product Manager

Location:Marlborough, MA or Bensalem, PA

Duties and Responsibilities
  • Help to define a product vision and strategy; maintaining and communicating the product release schedule.
  • Gather and document requirements for product releases. Ensuring good input is taken from regulatory, client and technical contacts.
  • Define development and release timelines, and manage the project from definition to release.
  • Utilise the issue tracking system and change control process, ensuring that the Development back-log is maintained.
  • Work with Development and QA team members to ensure that product updates are delivered on time and according to client expectations.
  • Be a product champion within the organization; ensuring a good understanding of existing features, and our client’s future expectations
  • Ensure correct prioritization of requirements based on both external and internal feedback.
  • Develop & implement processes to drive collaboration between, quality and product development and to ensure effective product management practices.
  • Supporting the Sales Team where needed during the product sales process.
Manager, Quality Assurance
The Quality Manager is responsible for managing the ACUTA Quality Management System (QMS). In other words, he/she must manage all ACUTA company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate standards and regulations. This a very critical role within the organization as the Quality Manager will be the “Go To” person for answers related to quality, covering product specifications, supplier requirements, testing, verification, audits, corrective actions, non-conformances, benchmarking and the voice of the customer.
Location: Marlborough, MA

Duties and Responsibilities
  • Quality Standards - Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained. Manage and control documents and records all throughout the company.
  • Quality Project Management – responsible for managing corrective action, process improvement, and auditing projects.
  • Business Process Documentation - must be able to understand, comply, and improve established company policies and procedures. Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.
  • Document Control - knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining company’s compliance program.
  • Quality Communications - Explaining business process compliance to others. Asking questions, collecting business process information, and working with others in a positive and collaborative manner.
  • Quality Auditing - performs quality audits. Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
  • Problem Solving - solves problems, typically in situations where general standardization should exist, but may not be operating effectively.
  • Team Player - is involved in teams and meetings at every level of the organization. Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.
Detailed Responsibilities
  • Report to top management on the performance of the QMS and any need for improvement.
  • Ensure the promotion of awareness of customer requirements throughout the organization.
  • Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS.
  • Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
  • Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS.
  • Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed.
  • Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.
  • Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained.
  • Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case.
  • Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
  • Coordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed.
  • Responsible for implementing and managing the Quality review and oversight of software products developed by ACUTA.
  • Implement & monitor quality improvements in products and services.
  • Monitor performance measures that include those measurements critical to customer satisfaction and compliance.
  • Responsible for attending and hosting customer audits and follow-up on the findings with a plan of remediation.
Solution Specialist – Client Services

The Solution Specialist supports sales productivity and deal flow by providing technology solutions during pre-sales efforts. The individual collaborates with sales, service, engineering, and technical support resources to ensure proposed deals include technical solutions that accurately address customer requirements, and are appropriately supported by key customer technical decision-makers. The successful candidate will manage multiple projects under moderate supervision.

Location: Bensalem, PA

Duties and Responsibilities
  • Provides product demos
    o Full Product lifecycle
    o Custom
    o‘What’s New’
  • Manages RFI/RFPs.
  • Proactively scopes the technical solution required to address customer requirements, assesses customer’s needs, and recommends solutions that optimize value for both the customer and ACUTA.
  • Maintains active knowledge of all ACUTA products.
  • Manages the pilot/evaluation process.
  • Minimum of 3 years of sales or sales engineering experience.
  • Understanding GxP Regulations such as 21-CFR Part 11 guidance and system validation requirements in the Life Sciences industry.
  • Understanding of the Life Sciences industry and in particular the drug development lifecycle process.
  • Understands various regulatory submissions and recognize the differences.
  • Understands the needs, guidelines and complexities of electronic publishing.

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