Remote Senior IT Quality Control Specialist job in Seattle, WA
Vacancy has expired
Seattle, WA CorTech LLC
| Job Ref: | 371395 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 47.50/Per Hour |
| Remote: | No |
Location |
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| City: | Seattle, WA |
| Post Code: | 98101 |
| Map: |
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Description |
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JobsRUs.com is seeking to hire a Senior IT Quality Control Specialist for our client! Benefits Available! Weekly Pay! Fully Remote Position! Pay Rate - $47.50/hr 1st Shift: Monday-Friday, 8am-5pm Job Description The Senior Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. Client is seeking a consultant with strong QA oversight experience in computerized systems validation (CSV) and remediation initiatives. The ideal candidate has hands-on expertise with periodic reviews, a solid working knowledge of FDA Computer Software Assurance (CSA) principles, and a track record of ensuring compliance in regulated environments. They are looking for a high-energy, collaborative professional who communicates clearly, confidently, and can integrate effectively with cross-functional teams. · Provides guidance and support to operational teams within Sarah Cannon Research Institute to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. · Works closely and effectively with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts. Duties include but are not limited to: · Provides guidance to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversees quality activities related to software, process, and data integrity validation. · Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy. · Provides quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols. · Conducts and/or assists with periodic review of system documentation according to defined schedule to ensure continued compliance with SOPs, corporate policies, standards, and government regulations. · Provides quality review and approval of change request documentation related to changes that impact validated systems and/or processes. · Supports the preparation, hosting, and follow-up of Sponsor audits/assessments and regulatory inspections where necessary. · Participates in the development and/or review of IT standards, policies, procedures, work instructions, forms, and templates to support the QMS. · Educates, trains, and mentors staff in QMS processes and quality improvement methods. · Attends training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends. · Participates or leads divisional improvement efforts. Performs related work as requested. · Stays abreast of final FDA regulations and guidance documents ensuring compliance. · Reviews draft guidance documents assessing existing validation processes to identify potential changes to the validation process. Works with Director and Consulting Validation Engineer to implement process changes for compliance with updated/future regulatory guidance documents. · Performs other duties as assigned. Required Knowledge, Skills, and Abilities · Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation and CSA guidelines. · Knowledge of EU regulations, e.g., Annex 11 is helpful. · Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful. · Strong QA oversight experience in computerized systems validation (CSV) and remediation initiatives. · Solid working knowledge of FDA Computer Software Assurance (CSA) principles, and a track record of ensuring compliance in regulated environments. · Hands on experience with periodic reviews. · Professional demeanor and positive attitude; excellent communication and inter-personal skills. · Strong analytical skills, attention to detail, writing and documentation skills and a passion for quality. · The ability to work as part of a cross-disciplinary team and relate to a diverse number of co-workers. · Ability to define, learn, understand, and apply new technologies, methods, and processes. · Good time management and organization skills · Professional writing and communication skills interpersonal skills · Professional demeanor and positive attitude; excellent communication and inter-personal skills. Required Education and Experience Bachelors degree in a related is required, a Masters degree is preferred. 5+ years of relevant experience required. | |
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