QA CSV Specialist

Our major pharmaceutical client is seeking a talented and driven individual to join their Quality Assurance Computer System Validation (CSV) team, for the launch of a new facility at West Point, PA. The candidate will play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations. This role presents an exciting opportunity to be part of a dynamic team and make a significant impact on the quality and reliability of our systems in a cutting-edge environment.

Primary Responsibilities

Position Description:

• 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.
• 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 reoccurrences.
• 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 to regulation 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
  
  

Position Qualifications

Required Experience and Skills:

• 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 And Skills

• 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 Kneet software.
  
  

Education Minimum Requirement

• B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.