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Software Guidance & Assistance, Inc., (SGA), is searching for a QA Specialist, Document Control for a CONTRACT assignment with one of our premier BioTech clients in Cambridge, MA. Responsibilities :
- The QA Specialist leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations, and systems.
- The Specialist is responsible in order of business priority for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and making recommendations to improve the quality of processes and products.
- Regular onsite work at a designated location is an essential function of this role.
- Utilize an electronic Document Management System (eDMS).
- Assist in all aspects of the full operation, implementation, and maintenance of the electronic document management system for controlled issue, retrieval, archiving of CLIA, CAP, and FDA regulated documents to support site operations.
- Responsible for maintaining, updating, and versioning of policies and procedures.
- 5+ years of Quality Assurance experience in a medical device, diagnostics, clinical laboratory or biopharmaceutical industry preferably in a QA environment, OR Associates degree in science or related field
- Perform document compliance editing checks on controlled documents (SOPs, Instructions, Material Specifications, Analytical Methods, Validation Protocols, etc.) prior to sending for review and approval.
- Assist document owners in creating documents and workflows in eDMS.
- Ensure that documents render properly in eDMS and troubleshoot any rendering issues.
- Ensure that the appropriate reviewers and approvers are assigned to documents.
- Maintain organization and attention to detail in a fast-paced workflow environment.
- Manage all documents within the QMS according to the SOP Lifecycle Program.
- Organize Quality Assurance documents so they are readily retrievable.
- Support FDA and other regulatory agency inspections for backroom support/document retrieval.
- Work with management in compiling required metrics and data for Management Review to meet
- ID: #23500448
- State: Massachusetts Cambridge 02138 Cambridge USA
- City: Cambridge
- Salary: USD TBD TBD
- Job type: Contract
- Showed: 2021-11-26
- Deadline: 2022-01-24
- Category: Software/QA/DBA/etc