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QA Specialist *$1,000 HIRING BONUS*

Company: CareerLink
Location: Omaha
Posted on: November 22, 2021

Job Description:

$1,000 Hiring Bonus Job --Summary: Perform Quality Assurance (QA) functions to build, uphold, and improve the Company's Quality Systems. Essential Duties and Responsibilities: Applicable to all levels of position Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes. Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance. Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements. Perform --training and manage the Quality System's Training Program. Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records). Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements. Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution. Make changes to SOPs, policies, training materials, and other documents in the records management system. Assist during regulatory inspections. Interface with various Divisions in problem resolution, and continual improvement. Support manufacturing failure investigations, define investigational strategy. Facilitate meetings. Apply discretion in decision making. Demonstrate independent judgment and make recommendations regarding business practices. Formulate, implement, interpret and affect policies and operating practices. Communicate effectively with others. Maintain a good attendance record. Perform work onsite. Perform other duties as assigned. Quality Specialist 1 (Considered Entry Level Position therefore requiring most supervision/mentoring) Quality Specialist 2 Perform at an experienced and functional level therefore requiring limited supervision. Engage in Professional Development Activities. Quality Specialist 3 (All Quality Specialist 1 and 2 skills as well). Subject Matter Expert in Quality Assurance functions and GMP functions. Function with little supervision. Keep current on industry regulations. Perform gap analysis of quality and analyze monthly trending reports of key quality indicators for manufacturing to ensure continuous quality improvement. Recommend and implement modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability, i.e. validation support. Provide supervisor support on selected, large-scope projects involving data collection and/or research small scope individual topics drafting recommendations to QA management. Mentor co-workers and internal customers with interpretation of regulatory requirements (e.g., Good Laboratory Practices (GLPs), SOP requirements, and other guidance documents, as applicable. Notify management of quality/compliance trends and service failures. Quality Specialist 4 (All Quality Specialist 1, 2, and 3 skills as well) Act as an alternate supervisor in supervisor's absence. Act as QA subject matter expert. Make decisions autonomously. Function without minimal supervision. Function as a lead with the Supervisor present. Develop and implement appropriate programs and syst

Keywords: CareerLink, Omaha , QA Specialist *$1,000 HIRING BONUS*, Other , Omaha, Nebraska

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