- About Company: JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance. JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
ABOUT THE ROLE
Translate the client’s GMP Quality Control laboratory processes for Stability Management and Reagent and Standard Inventory into approved workflows, clear and testable requirements, operational procedures, and training materials for the expansion of a validated LabWare Laboratory Information Management System (LIMS). Serve as the functional link between laboratory SMEs, configuration consultants, validation resources, Quality, and Document Control, while ensuring that procedural and validation deliverables remain accurate, consistent, and inspection-ready. The LIMS Functional Analysis and Compliance Documentation Specialist will work in a hybrid model supporting a client in the life sciences industry. Workflow analysis, requirements support, procedure development, document review, and project meetings may be performed remotely, with onsite presence at the client facility in Rancho Cordova, California, for workflow sessions and key reviews as required. The role operates within a GMP-regulated Quality Control laboratory and computerized-systems environment. Allocation may vary by phase, with higher demand during design, procedure development, and go-live readiness. Candidates must be legally authorized to work in the United States.
RESPONSIBILITIES
Facilitate workflow and requirements sessions with laboratory SMEs and stakeholders to document activity sequences, user interactions, business rules, roles, approvals, controls, and exception paths.
- Document Stability Management workflows, including study planning, sample placement, pull scheduling, retrieval and login, testing, evaluation, trending, investigation management, chamber management, completion, and reporting.
- Document Reagent and Standard Inventory workflows, including receipt, registration, labeling, storage, preparation, standard qualification, usage, expiration, disposal, and reporting.
- Prepare process maps, workflow definitions, use cases, and other supporting artifacts that provide clear source material for configuration, requirements, testing, and procedures.
- Support development of the User Requirements Specification and acceptance criteria, ensuring that business and regulatory expectations are captured as clear and testable requirements.
- Review application design and configuration information for alignment with approved workflows and requirements and identify gaps or impacts early.
- Define user roles and security permissions for applicable workflows, considering segregation of duties and data integrity controls.
- Support master data planning and define functional verification criteria for stability and inventory data.
- Participate in iterative Build-phase reviews and incremental end-user testing; track functional changes and communicate validation and documentation impacts.
- Provide functional input to data risk and data integrity assessments and support the design of realistic qualification scenarios and test data.
- Develop and revise the LIMS Administration Procedure and operational procedures for Stability Management and Reagent and Standard Inventory using client-approved templates.
- Ensure procedures incorporate approved functionality, business processes, user responsibilities, exception handling, electronic records and signatures, audit trail review, and other applicable GMP controls.
- Identify existing procedures, forms, or work instructions affected by the new functionality and communicate potential impacts to the client.
- Coordinate document review and approval cycles, consolidate and resolve reviewer comments, and track document status, versions, reviewers, and approval dates.
- Perform Good Documentation Practices and editorial quality reviews of validation and procedural deliverables for consistency, terminology, template compliance, and cross-references.
- Develop training materials and job aids and support user training, knowledge transfer, go-live readiness, and post-go-live functional support, as required.
- Comply with client and JCA Quality Management System requirements, including training, document control, and confidentiality obligations.
REQUIREMENTS & QUALIFICATIONS
Education
- Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Information Systems, Communications, or a related scientific or technical field.
- An equivalent combination of education and directly related GMP laboratory systems experience may be considered.
Experience
- Minimum of five (5) years of experience in a GMP Quality Control laboratory, laboratory systems, Quality Assurance, compliance, validation, or technical writing role in the pharmaceutical, biotechnology, or other GMP-regulated industry.
- Minimum of three (3) years of hands-on functional experience with an enterprise LIMS through configuration, administration, business analysis, implementation, or operational use.
- Experience facilitating requirements or workflow sessions and developing process maps, requirements, or acceptance criteria.
- Experience authoring or revising GMP procedures for computerized systems or laboratory operations.
- Experience managing document review, approval, and comment-resolution cycles.
- Experience working within change control processes for computerized systems.
Preferred
- Direct hands-on LabWare LIMS configuration, administration, business analysis, or implementation experience.
- Experience with Stability Management and Reagent and Standard Inventory functionality.
- Experience with master data creation or loading for stability studies and inventory.
- Experience with LIMS–ERP data flows related to material or quality disposition.
- Experience reviewing Computer System Validation deliverables or supporting qualification testing.
- Experience developing and delivering LIMS user training.
- Knowledge of electronic document management systems such as Veeva Vault, MasterControl, or Documentum.
- Prior QC laboratory experience or experience as a LIMS end user.
SKILLS Technical Skills
- Strong knowledge of GMP Quality Control laboratory processes, including stability programs and reagent and standard management.
- Knowledge of LIMS functional concepts, including master data, analyses, specifications, stability protocols, inventory, workflows, user roles, security, audit trails, and reporting.
- Ability to facilitate workshops and translate business processes and SME input into clear workflows, requirements, acceptance criteria, procedures, and training materials.
- Strong knowledge of GMP documentation practices, Good Documentation Practices, ALCOA+ principles, and document-control processes.
- Working knowledge of 21 CFR Part 11, 21 CFR Parts 210 and 211, and data integrity requirements for computerized systems.
- Process-mapping skills using tools such as Microsoft Visio and swimlane or BPMN notation.
- Excellent technical writing and editorial review skills in English.
- Strong organization and attention to detail when managing multiple documents, priorities, and review cycles.
- Proficiency in Microsoft Office applications, including advanced Microsoft Word capabilities.
- Excellent oral and written communication skills in English; Spanish is a plus.
- Collaborative, client-focused, and able to work independently with minimal supervision.
Soft Skills
- Strong attention to detail and commitment to documentation accuracy
- Clear and proactive communication across multidisciplinary teams
- Ability to work independently in a structured field environment
- Organized, methodical, and adaptable under project timelines
- Team-oriented with a collaborative approach to problem solving
- Willingness to work on-site during testing, startup, and qualification phases
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