Information Systems Compliance Specialist II
Duarte, CA, United States
Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience’s mission! Take a look at this opportunity with our Quality Assurance team, which is seeking a passionate individual, to fill the role of our Information Systems Compliance Specialist II.
The Information Systems (IS) Compliance Specialist II is responsible for review and approval of quality systems and compliance in all areas of computerized hardware and computer system applications to include applicable website changes for Prolacta. Works closely with IT department and business owners to develop new user functionality and expand existing user functionality of individual systems. This position serves as a resource to department and operations on computer-related quality and regulatory issues in the framework of the SDLC model, CSA, CSV and applicable Prolacta Standard Operating Procedures, and state and federal regulations (i.e. CFR 21 Part 11 and Part 820).
Who Is Prolacta Bioscience?
We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world’s leading hospital provider of 100% human milk– based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.
For more information, please visit www.prolacta.com
How you will contribute
This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by…
Understanding and providing guidance on quality procedures, safety procedures, IT procedures, cGXP procedures and systems as well as state and federal regulations.
Providing Quality guidance for IT project activities; project initiation, scheduling, high impact projects, ensuring that comprehensive project, quality, and risk documentation is prepared and maintained. Develop and/or review and approve validation documentation as needed.
Identifying and completing continuous improvement activities.
Assessing IT vendor/supplier qualification and ability to perform external audits.
Providing feedback and guidance for IT projects and ensure risk mitigations are properly identified throughout the project life cycle.
Other duties and responsibilities
Perform technical review and approve requirements specifications and verification methods, procedures, and results, which are communicated through requirement specifications, analysis, demonstration, inspection, test, and simulation results to ensure documentation is completed according to defined standards and guidance.
Work with assigned teams to identify and resolves conflicts, roadblocks, and issues.
Perform technical review and approval of validation protocols, requirements, integration, verification, and validation traceability Matrixes as needed.
Participate in review of documentation to ensure product/system fulfills its intended use when placed in its intended environment (i.e. conforms to the customers functional requirements; and meets the expected safety criteria, quality, and reliability standards).
Provides GXP guidance to the team for SOP and written standards (e.g., FDA), providing additional information as needed to ensure consistent application of quality processes.
Collaborate with IT to improve requirements, development, and verification processes.
Review observation reports, non-conformance investigations to ensure timely completion of investigation.
Maintain Standard Operating Procedures (SOPs), User Guides, and other relevant application documentation.
Maintain and track team metrics.
What you bring to the role
Bachelor’s degree in electronic, mechanical, or software engineering, computer science, or related field.
Experience in multiple validation disciplines including manufacturing process validation, hardware/software system validation, equipment qualification, and facilities validation.
Experience in participating in regulatory agency inspections and/or internal audits with focus on validation activities.
Verification and Validation experience using risk-based approach (P-FMEAs, etc).
Ability to collaborate effectively within multiple discipline teams with the ability to review and understand technical documentation.
Experience with reviewing documentation for all internal software application launches.
Experience with evaluation of system documentation submissions to ensure successful transitions.
Knowledge of computer environments, standards development, and system life cycle methodology.
Knowledge of change control process to ensure proper completion of change control life cycle (website change control, hardware change control and software change control).
Knowledge of cGMP/ICH/FDA regulations with 21 CFR Part 11, 21CFR Part 820, and GAMP knowledge. Pharmaceutical, Blood Products, or Biotech industry quality and IT activities preferred.
Experience/background in blood banking, medical fields (pharmaceutical, hospital, etc.).
8+ years Software Quality Assurance or Engineering (SQA or SQE).
3+ years IT auditing.
6+ years SDLC (Waterfall, Rapid Prototype, Spiral, Agile, etc.).
10+ years overall IT experience (can include experience timeframes from above).
5+ years of work experience within the Pharmaceutical, Biological, or Biotech Industry
Experience with IT practices (COBIT, ITIL, ISO, SEI, CSA, CSV etc.).
Experience with testing tools (HP ALM, Quality Center, Quick Test Pro, Load Runner, etc.).
Experience on multi-disciple technical project teams as the validation subject matter expert.
Experience in highly regulated field (FDA, FAA, DoD, SEC, etc.).
Excellent interpersonal skills to maintain partnerships between Quality and IT and to ensure the lines of communication are professional and congenial.
Must be flexible with hours to accommodate production/business needs.
How Prolacta benefits you
To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on your first day, to discretionary stock options and 401(k) match, we value our employees’ health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.
What else do you need to know
Location: City of Industry and Duarte, CA
Schedule: Monday-Friday, 8am to 5pm, may require some flexibility when needed
Travel: minimal – 15%
FLSA: Exempt
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