USA - Quality Associate I
 Equiliem | |
 United States, New York, Skaneateles | |
 Feb 17, 2025 | |
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This position is responsible for parts of the activities within Document Control and Training Requirements. Quality Associate I, Training & Document Control will identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
II. ESSENTIAL FUNCTIONS: This position supports, monitors and maintains the day-to-day training and record control process for within Operations & Quality. The position also has responsibility to work closely with various Supervisors at the facility to monitor and maintain a central computerized training database of all employees at the facility. Specific responsibilities may include, but are not limited to: Training: * Manages and monitors training completion via BaxU. Supports Managers and Supervisors for training evidence completions. * Provide and support training activities for New Employee Orientation (NEO). Provide training, guidance and coaching in the areas of responsibility. * Works with Managers and/or Lead Trainers to ensure training plans are developed for every job description and updated as necessary. * Works with Human Resources to ensure Job Descriptions are written and updated as necessary. * Manage and communicate training metrics. * Work with managers to organize/schedule training events as needed. Documentation: * Ensures efficient processing of document and change management systems for the Quality Management System. * Monitor the functional activities and employees associated with the creation, revision, issuance, review and storage of controlled quality records in compliance with GDP's. Ensure documents, forms, and records are accurate and complete. * Ensures that records of changes to documents are maintained in accordance with regulatory requirements. III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED * Must have computer proficiency with solid experience in Microsoft Word, Excel, Adobe Acrobat, and other systems. * Ability to work effectively as part of a cross functional team. * Ability to relate and work well with people. * Excellent organizational and verbal/written communication skills. * Attention to detail. IV. EDUCATION/EXPERIENCE REQUIRED * BS in business, science, or engineering required. * 1+ years' experience in Quality with a medical device/pharma or other regulated industry. * Experience in development and maintenance of a training documentation database preferred. V. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: * Must be able to sit for most of the work day. * Ability to stand or walk for long periods as well. * Must have good hand to eye coordination and dexterity * Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time. VI. WORK ENVIRONMENT Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to: * Wearing a static protective smock at all times while in the work area * Wearing a ground wrist strap and plugging that wrist strap into the working table. * Working in close proximity to other employees. * Working in an environment that is temperature and humidity controlled. | |