Qualifications:
Please select Physical Requirements under Skills section.
Responsibilities:
Support the manufacturing, quality assurance, engineering and a variety of other departments by incorporating subject matter expert comments into well-constructed and easy-to-read approvable documents. Edit/write a variety of technical articles, reports, manuals, flow charts, and other documentation for a wide range of uses, including GMP operations and validation activities. Edit/create presentations, charts, diagrams, graphics, and research documentation. Write test scripts. Assist data entry, report generation, accuracy checks and tracking. Assist in assembly of validation package documents for GMP libraries. Client is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Being on a temporary contractor assignment at Client means working in an innovative culture where you have the opportunity to support the work of thousands of others around the globe dedicated to improving the lives of others. Client discovers and brings life-changing medicines to those who need them, improves the understanding and management of disease, and gives back to communities through philanthropy and volunteerism. Client passionately promotes food security and fosters the human-animal bond to enrich the lives of its customers and the customers they serve as well. Our values: integrity, excellence, respect for people. Greater than 90% of workers rate their Client assignment as above average or excellent.
Focused Responsibilities are:• Performs the planning, writing and editing of QA documentation required for compliance with the GQS and LQS policies and applicable departmental guidelines • Analyzes existing documentation to ensure it meets GQS/LQS criteria • Makes recommendations during gap assessments and with regard to documentation format • Functions as the point person in QA for documentation advice • Reports status of documentation deliverable to supervisor and Site Quality Leader • Helps organize existing and new documentation • Assists in the Periodic Review, Gap Assessment, AQMS, and other review strategy documen-tation • Facilitates the routing of documentation produced through the review and approval processes
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