Company
Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the material for the products Prolacta sells
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, ERP systems, interpret them into functional requirements and formulate detailed test cases for each requirement.
Primary Duties and Responsibilities
• Document and understand current as-is processes, collaborate with SMEs to design desired process, performs detailed gap analysis and recommend business process improvements
• Produce high-quality documentation (e.g. Process Flow charts, stories, FRS, Test Plan, Test Cases, Test Scripts, Summary Reports, SOPs, Training Manuals etc) that meets applicable standards and is appropriate for its intended audience
• Perform Product Owner functions such as ensuring backlogs are updated, prioritized regularly, define sprint goals, develop and maintain Product Vision & Roadmap, and ensure our SOPs are adhered to in the execution of tasks.
• Lead 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
• Collaborate with outsourced global resources in the creation and maintenance of software
• Lead mid to large enterprise projects independently as a lead analyst
• Work closely with business stakeholders and participate in establishing the product roadmap for the organization
• Works closely with the Prolacta Quality team to insure compliance with regulatory requirements
• Participates in special projects and/ or other assignments as required
• Works with the IT team by improving processes, developing standards, improving project documentation and procedures
• Perform regular one on one meetings with subordinates as part of performance reviews as required
Job Requirements and Qualifications
• Proven working experience in technical writing of software documentation (8+ years) and related experience, 3+ years as a Principal/Senior Business Analyst or BA Manager
• Prior experience/ Working knowledge in FDA regulated and/or Biologic companies desired
• Experience in 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations and GAMP Methodologies
• Strong knowledge of and proven experience in full scale implementation of ERP Systems with focus on Finance and Manufacturing including post production support (5+ years)
• 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, Stories, Continuous Integration etc. preferable
• Strong quantitative, critical thinking, analytical and problem-solving skills.
• University degree in Information Systems, Computer Science, Engineering or equivalent preferred
Work Environment (Location, travel, shift, on-call, etc.)
Location:
Duarte Office; occasional travel to the City of Industry Office
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to walk, sit, use hands to finger, handle, or feel and reach, talk or hear. The employee is occasionally required to stoop, kneel, crouch or crawl. Employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
Disclosure
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.”