Urgent! CSA Validation Subject Matter Expert (SME) Job Opening In Queens – Now Hiring SGA
Software Guidance & Assistance, Inc., (SGA), is searching for an CSA Validation Subject Matter Expert (SME) for a RIGHT TO HIRE assignment with one of our premier Beauty clients in LIC , New York.
Responsibilities :
The CSA Validation SME is a key stakeholder in the ELC CSA Center of Excellence (COE).
The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity.
Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s).
The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.
Responsibilities:
• Provide insight and expertise on validation project risk and complexity
• Maintain validation best practices
• Gather project information from system owner(s)
• Collaborate with the Business Analyst on a frequent basis
• Maintain compliance with Good Documentation Practices (GDP)
• Aid in writing and reviewing of reports summarizing system CSA validation execution
• Collect feedback from System Owner(s) on deliverables
• Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary
• Draft, review, and execute other validation documents when necessary
Qualifications:
• Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree
• -+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance
• Aptitude in GAMP and CFR Part standards
• Previous experience in a GxP industry or a life sciences industry is required
• Technical competency in FDA regulations
• Expertise in generating, reviewing, and addressing CAPAs
• Strong written and verbal communication skills
• Strong ability to collaborate with the team
• Ability to work self-directed in the timely completion of project deliverables
• Practical experience with Data Integrity and ALCOA+ is a plus
Demonstrated Competencies:
• Technical Competency – Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials
• Time Management – Able to follow strict deadlines, prioritize tasks, and work well under pressure
• Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information
• Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines
• Strong written and verbal communication skills
• Strong ability to communicate with other COE team members
• Strong analytical and problem-solving abilities
• Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality
• Adept at solution development and project scoping
• Effectively collaborate with peers, cross-functional teams, and departments
• Strong technical background is preferred
Must Have:
Extensive experience in the Medical, Pharma or Regulatory Compliance Industries
Strong CSA experience as they will be acting as the SME
Must have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work with
Agile experience/knowledge highly preferred.
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Unlock Your CSA Validation Potential: Insight & Career Growth Guide
Real-time CSA Validation Jobs Trends in Queens, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for CSA Validation in Queens, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 2362 jobs in United States and 2 jobs in Queens. This comprehensive analysis highlights market share and opportunities for professionals in CSA Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! SGA is currently hiring and seeking a CSA Validation Subject Matter Expert (SME) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: CSA Validation Subject Matter Expert (SME) Jobs Queens.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at SGA adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a CSA Validation Subject Matter Expert (SME) Jobs United States varies, but the pay scale is rated "Standard" in Queens. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for CSA Validation Subject Matter Expert (SME) typically include Computer Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your CSA Validation Subject Matter Expert (SME) interview at SGA, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the SGA's products or services and be prepared to discuss how you can contribute to their success.
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