IntePros · 14 hours ago
QA CSV Specialist
West Point, PA
Full-time
Onsite
Senior Level
5+ years expIntePros is seeking a talented and driven individual to join their Quality Assurance Facilities and Validation team for the launch of a new facility at West Point, PA. The candidate will ensure compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of operations and making a significant impact on the quality and reliability of systems.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operations
Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing
Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations
Enforces Good Documentation Practices and ensures that SDLC deliverables are properly catalogued and available for internal and external regulatory inspection
Provide additional support with SDLC deliverables for Enterprise Application support, as applicable
Attend meetings as quality representative, escalating items as appropriate
Supports team’s progress and accomplishments on validation activities ensuring project remains on target for key milestones
Qualification
Required
B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline
At least 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment
Industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions
High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration
High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management
Extensive experience providing oversight for adherence to enterprise SLC and procedures
Experience in creation, execution, and reviewing a change control document
Proficient skills dealing with and understanding typical laboratory facilities and equipment
Ability to prioritize and manage multiple initiatives, projects concurrently
Excellent interpersonal skills including ability to work as a team member in a collaborative environment
Excellent written and communication skills including thorough knowledge of Good Documentation Practices
Possess excellent time management skills
High attention to detail
Able to work autonomously / independently
Can work through problems and can create alternate solutions
Knows when to raise issues
Preferred
Experience with Project Management principles
Experience with PowerBI
Expertise with end-to-end data governance
Knowledge of published regulatory agency data integrity, computer software assurance guidance
Moderate level of experience with electronic tools such as software providing document management and testing capabilities
Experience using Kneat software
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
Company data provided by crunchbase