QA CSV Specialist - Katalyst Healthcares & Life Sciences

• 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.

• Lead validation teams on understanding validation best practices and applying quality principles.

• Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.

• Identifies and resolves issues interfering with execution of deliverables.

• Implements practices designed to eliminate or minimize recurrences.

• 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.

• Perform Supplier Assessments to ensure vendor compliance with regulations and standards before introducing instruments or applications into the lab environment.

• Attend meetings as quality representative and capture meeting minutes, escalating items as appropriate.

• Oversee team's progress and accomplishments on instrument validation activities ensuring project remains on target for key milestones.

• Position requires individual to be on-site (West Point, PA or Springhouse, PA) an average of 4 days/week; dependent on operations.

Requirements:

• 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 experiences include 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 and 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.

• High attention to detail.

• Able to work autonomously / independently.

• Can work through problems and can create alternate solutions.

• Knows when to raise issues.

• Experience with Project Management principles preferred.

• Experience with PowerBI preferred.

• Expertise with end-to-end data governance preferred.

• Knowledge of published regulatory agency data integrity, computer software assurance guidance preferred.

• Moderate level of experience with electronic tools such as software providing document management and testing capabilities preferred.

• Experience using Kneet software preferred.