| Urgent Hiring || Senior QA Specialist | Rensselaer, NY | Contract at Rensselaer, New York, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2299266&uid= From: Pallavi Singh, Tek Inspirations [email protected] Reply to: [email protected] Job Description - Title: Senior QA Specialist Duration: 6+ Month CTH Locations Rensselaer, NY Visa: USC/GC/GC-EAD/H4-EAD Rate: $60/hr. Domain: biotech/pharma industry Manager Note: This role is supporting IT Quality and Data Integrity, establish policies and procedures to ensure compliance with GxP regulations, CAPAS, sop's. FDA regulated environment The candidate ideally would have experience working both on IT Infrastructure and applications and would be able to provide the necessary guidance in process/procedural updates, as well to support reviews of periodic monitoring (user/service account reviews), and periodic evaluation reviews of these IT technologies. This is a QA Validation person, who worked extensively in the manufacturing / lab side, when it comes to Investigations and CAPAs Do they have specific experience with deviations related to IT systems/applications If so, which IT systems have they supported deviation investigations with resultant CAPA plans Responsibilities: Ensure IT processes and procedures meet Quality System requirements. Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives. Provides support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc. Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits. Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process. Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation proces Assist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity Qualifications: 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment. Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing) Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements. Understanding of root cause analysis and risk management techniques. Experience with quality management systems including change control, incident management, and deviation management Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc. Education & Certifications: Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, Information Technology) preferred. Regards, Pallavi Singh Technical Recruiter TEK Inspirations LLC : 13573 Tabasco Cat Trail, Frisco, TX 75035 Email: [email protected] : linkedin.com/in/pallavi-singh-993483189 Disclaimer: If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line to [email protected]. And mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Keywords: quality analyst information technology green card New York Texas Urgent Hiring || Senior QA Specialist | Rensselaer, NY | Contract [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2299266&uid= |
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| 03:51 AM 29-Mar-25 |