Senior Qa Associate - (US-NC-Durham - 27722)

Minimum Education: None
Job Type: Full Time
Jobcode: N/A
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Responsibilities: Work directly with teams to establish current state process maps, value stream maps, and future state maps. Translate process maps through technical writing into functional SOPs and coordinate the approval process. Document user requirements specific to the business solutions. Ensure final business solutions (as applicable) developed by Business Analysts and others meet all corporate policy standards and fulfill business requirements. Establish and coordinate periodic document reviews for accuracy and relevance by business owners. Work with business lines to map critical SOPs to training needs and set up P2L accordingly for onboarding and periodic re-training. Serve as P2L subject matter expert and liaison. Coordinate the translation of documents into other languages for global use as needed. Review study protocols and final reports, working directly with document owners to establish sound study documentation packages. Maintain current information on applicable government regulations and corporate policies and review study documentation for compliance to those policies. Maintain and oversee document control (SOPs, forms, work instructions, manuals, policies), including development and maintenance of associated policies, databases, master lists, and document management programs and software. Oversee integration of legacy systems into company GDMS as needed. Ensure that all standard operating procedures governing document control and study records development are periodically reviewed and updated when necessary. Provide support for corporate and divisional groups during regulatory inspections and internal audits as required. Interact directly with colleagues to offer guidance and training in routine documentation and compliance procedures including document control; conduct training seminars. Maintain membership on and assist the Chairman of the Institutional Animal Care Committee in matters concerning compliance with company animal care policy. Requirements: 4 year college degree, preferably with a science focus. At least 3 years experience in a research and/or manufacturing environment. Knowledge of applicable animal health government regulations including USDA, FDA, etc. Certification in Six Sigma, Lean Manufacturing, and/or ISO methodologies preferred Excellent interpersonal skills, written and oral communication, and attention to detail. Experience with root cause analysis, value stream mapping, corrective action plans, design of experiments, technical writing preferred. .

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