QA/IT Specialist Consultant
215 First St, Cambridge, MA 02142 Cambridge, MA 02142 US
General Scope and Summary We are seeking a highly motivated individual to join our geographically distributed QAIT team as a QAIT Specialist Consultant. The ideal candidate will interface and build strong partnerships with other teams. Suitable candidates must thrive and excel in an environment that embraces “putting people first”, teamwork, continuous improvement and change, risk-based decision making, and flexibility. Successful candidates must be self-motivated to take actions, attentive to detail, open to sharing ideas and learning new concepts, comfortable dealing with healthy/productive conflict and conflict resolution, and have excellent critical and communication (written and verbal) skills. Roles and Responsibilities Review/comment on, create, amend, and approve/reject change control requests. Review/comment on CSV strategies and deliverables and periodic review summary reports. Actively participate in, review/comment on, and support the processing of Quality records (e.g., Deviations and CAPAs) for GxP systems throughout their entire lifecycle. Actively participate in system/requirements/specification risk assessment sessions. Actively participate in review/comment and assessment of (SaaS) release notes to define testing coverage and level of testing rigor. Evaluate project timelines to correctly ascertain proper time/resource estimates. Support weekly/monthly/quarterly performance metrics reportable to Senior Leadership as needed.
Education, Experience, and Specialized Knowledge and Skills
Basic Qualifications 3+ years of demonstrable, practical experience in the following areas: Providing QA specialist/review support and oversight of Computerized Systems Validation (CSV) activities related to initial implementation, change control, and decommission of GxP (i.e., GCP, GPV, and GMP) systems such as?Argus, LIMS, LMS, AE/PC/MI Intake, Veeva Vaults (e.g., QualityDocs and QMS), ServiceNow, SAS, SFTP, TraceLink, REMS, ERP, SharePoint, and NonMem. Providing QA specialist/review support and oversight of CSV and Contract Service Provider (CSP) activities related to GxP systems deployed as SaaS by their original development organizations, as well as those hosted by another 3rd party CSPs. GAMP-based risk assessment and risk management approach. 21 CFR Parts 11 & 820 and Annex 11 regulations, as well as GAMP 5 best practices. Data integrity, periodic review, configuration management, software development and CSV lifecycles, and Agile/Scrum and Waterfall development approaches. Authoring/co-authoring of policies, SOPs, WIs, templates, job aids, and/or best practices.? Use of electronic systems supporting CSV activities (e.g., MicroFocus ALM and ValGenesis).
Preferred Qualifications Understanding of Computer Software Assurance (CSA) concepts (e.g., risk-based documentation and leveraging testing from “lower environments” and/or from CSPs). Understanding of various software testing techniques (e.g., static and dynamic testing). Experience with the validation of ERP and LIMS software products. Must have ability to work remotely 100% of the time from anywhere in the Continental US. Must have ability to work US East Coast hours (e.g., 0900-1700 hours), irrespective of geographical location. Sporadic (preauthorized, billable) extended hours (work week/weekend), when required, based on specific project needs (typical work demand is 40 hours/week).
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