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Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities. Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system.
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Use BitBucket, JFrog Artifactory, Atlassian, Bash, KSH, CI/CD, DEV, Git, QA, Ansible, REST API, Jira, Splunk, AppDynamics, Jenkins, SVN, Perforce, Agile, Red Hat Linux, Unix, Maven, Nexus, Dynatrace, Shell, Python, SSH, WebSphere, Apache Tomcat, XML, SQL Plus, XL Release, Confluence.
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Performance of QC analytical chemistry assays, HPLC, GC & GC/MS, Headspace, Moisture analyzer, Karl Fisher as well as wet chemistry assays. Collaborates with R&D to develop test methods for new products Performance of QC method qualification, validation and transfers.
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Conduct QA in the company’s programs, including ensuring Data Integrity in processes, data packages and reports to the Company’s external pharma and gene therapy partners. Interacting, reporting, and collaborating with PGN Global QA team.
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A day in the lifeAs a QA SDET on the Blink team, you are expected to bring passion to utilize and grow your industry-leading technical abilities that enable you to significantly improve automation test coverage and testing efficiency.
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Key Responsibilities/Essential Functions Perform routine QC testing in accordance with SOPs and cGMP guidelines. Summary of RolePerform routine and advanced testing on incoming radioactive and non-radioactive materials, reference standards, solutions, finished product release and stability in QC Laboratory.
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The QC Stability Specialist responsibilities include processing stability samples, collation of internal and external stability assay results, maintaining data trackers, entering stability data in LIMS, assisting with stability protocols and reports.
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The QA Compliance Specialist will be primarily responsible for review of all QC documentation including protocols, reports, CofTs, QC data, OOSs, QC related Quality Systems.
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Support to QC maintained all the time for internal and external audits following guideline including USFDA, Health Canada, cGMP, ISO, GLPs, company policies and procedures. The role is divided between QC compliance activities and QC laboratory GMP testing activities.
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Experience working with QC and QMS systems, preferably LabVantage, Empower, Veeva, TrackWise, MasterControl, etc. Possess an understanding of Quality Technologies/operations such as QMS, LIMS, CDS, and other Quality systems.
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Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.
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To carry out cleaning verification and validation to support the EMP. To assist in 2nd party auditing (suppliers) To assist in the training of new members in the QA team and Production Operatives.
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The Optical Communications Technology Group develops impactful classical and quantum technologies and system prototypes for use in a wide range of challenging environments including terrestrial, space and underwater applications.
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The Laboratory Technician must have experience in inventory control and routine lab maintenance and services.
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Proficiently perform QC analytical chemistry assays using HPLC, LC-MS, GC/GC-Headspace, Rheological techniques. As assigned, perform QC activities and procedures which are required to test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions.
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qa qc jobs Title: rad tech Company: Forrest Health in Billerica, MA
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