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Quality Assurance Document Control Specialist
- Buffalo, New York, United States
- Buffalo, New York, United States
Über
The QA Document Specialist will be responsible for maintaining the ISO standards for document control process and ensuring information integrity in accordance with established ISO 9001:2015 procedures. The person in this role must fully understand the requirements for the product and have a sense of responsibility towards our potential and existing customers. The successful individual will be able to work with hourly manufacturing team members and department managers to ensure adherence and ownership of the quality program and provide outstanding value and commitment to the organization in the most cost-effective manner within quality standards. Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. Works with all departments to receive, prepare, route, and track document change requests. Implements approved changes and maintains complete and accurate document change request records. Creates, formats, edits, routes, finalizes, files, and maintains all controlled documents. Coordinates with Subject Matter Experts (SMEs) to ensure document accuracy. Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released. Ensures periodic document reviews are completed in a timely manner. Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finding innovative, well thought-out solutions to problems. Manages corrective action, preventive action, and change control systems including creation, assignment, monitoring, verification, closure, and metrics/trending for all formal corrective actions. Conducts or coordinates training as required for cGMP, documentation, corrective actions, and complaints. Supports customer and regulatory audits as required. Participates on assigned project or LEAN teams. Prepares and distributes approved change control notification in line with customer requirements, includes the review and approval of customer specifications Other duties as may be assigned Skills & Qualifications
Bachelor’s degree in relevant field (e.g. Business Administration, Engineering, Data Analytics) is preferred. Consideration is given to Quality certifications and relevant experience Must have a minimum of 3-5 years of experience in production environment. Experience in ISO 9001, AS9100, or ISO 13485 is required. Experience in pharmaceutical, medical device, automotive, or other regulated industry is preferred. Experience in a lean manufacturing / six sigma environment is preferred Effective skills and ability with MS Office to create reports, spreadsheets, and presentations. Effective PC skills to learn and use ERP, SPC, Minitab, and other software as needed Must have excellent communication skills and be able to effectively work with others in a team environment. Must be able to read and interpret requirements, standards, drawings and specifications. Familiarity with all aspects of quality control/assurance techniques such as, corrective/preventative action plans, complaint handling, document control, and root cause investigations. Detail oriented with excellent time management and organization skills Highly compliance oriented to firmly adhere to principles of regulation and standards. Qualifications
Is knowledgeable of and follows applicable work instructions and current good manufacturing practices (cGMPs). Employee pays attention to detail. Employee completes paperwork accurately, neatly, and completely. Employee willingly works in different areas as assigned. Excellent time management skills and organization skills Ability to exercise good judgment in determining the reasonableness of actions. Ability to work with minimum supervision. Innovative with the ability to make sound suggestions for improvement. Highly compliance-oriented to firmly adhere to principles of regulation and standards. Must have excellent communication skills and be able to effectively work with others in a team environment. Salary range of $55,000- $70,000 annually
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Sprachkenntnisse
- English
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