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Document Control Associate

1 month ago

Victor, United States LSI Solutions Full time

LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres. We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient. POSITION TITLE: Document Control Associate SHIFT HOURS: 8:00AM - 5:00PM LOCATION: Onsite at LSI Solutions in Victor, NY HOURLY PAY RANGE: $21.00 - $26.00 JOB SUMMARY: The Document Control Associate (DCA) will coordinate change control for all quality system documentation and maintain the appropriate databases and files for all. The Document Control Associate will provide continued support to Engineering, Production, and Discovery throughout the design and manufacturing processes. This position ensures documents are appropriately controlled, approved, and available in LSI’s Quality Management System. ESSENTIAL FUNCTIONS: Document Control Associate I Maintain, administer, and support the Document Control electronic system, which includes: Performing preliminary reviews for all quality-controlled documentation in the system, which verifies document type, clarity, accuracy of references to other documentation or standards, and formatting, as well as conformance to any specified templates. Completing roll out tasks once documentation changes have been approved. Verifying all controlled documents are current and assign periodic review tasks to document owners throughout the organization. Entering data in ERP system when Bills of Manufacture and Item Masters are created or revised. Importing standards, regulations, and guidance documents into the system. Reporting overdue change request tasks to the Quality Assurance Manager on a monthly basis. Maintain historical change control documentation and records, including but not limited to audit reports, sterilization reports, and biocompatibility records. Perform administrative changes to documents. Assist various departments in managing of change requests in GAS. Perform periodic review and utilize subscription service for ensuring external standards are up to date. Provide support for projects as needed. Support internal and external audit activities as needed. Perform all other responsibilities as assigned. Document Control Associate II All essential functions listed above. Train others on document control responsibilities. Develop new and revise existing work instructions and procedures to support document control processes. Generate, analyze, and present data, charts, graphs etc. that measure the effectiveness of the document control program. Assist the Quality Assurance team in administering the training system and rolling out training assignments as required by document creations or revisions. EDUCATION & EXPERIENCE: High School Diploma or equivalent work experience, with Associate’s degree preferred. Experience in electronic document and record management is a plus. KNOWLEDGE, SKILLS & ABILITIES: Proficient in Microsoft Office and Adobe Acrobat Pro. Excellent written and verbal communication skills. Ability to exercise independent judgement as well as work alongside team members. Customer-focused and strong interpersonal skills. Ability to train personnel from all organizational levels on document control processes. Strong planning and organizational skills. Ability to multi-task and adjust to changing priorities. PHYSICAL DEMANDS AND WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Regularly required to sit; use hands to handle or feel and talk or hear. Occasionally required to stand; walk and stoop, kneel, crouch. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. GENEROUS LSI BENEFITS INCLUDE: Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts 15 Paid Holidays, PTO, Sick Time Medical, Vision and Dental effective first day of employment LSI SOLUTIONS® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran