Associate, Documentation

Baxter International Inc.•Medina, NY

5d•$60,600 - $82,500

About The Position

The Documentation Associate I provides support for document and change control activities to help ensure accurate and timely product and system releases. The role assists with reviewing, processing, maintaining, and filing controlled documents according to established procedures. It supports daily documentation operations, responds to routine requests and questions, assists with audits and change control activities, and participates in project and process improvement teams as needed. The position manages Iron Mountain/Records 365 archival and assists other Document personnel as necessary. The role supports document configuration and product data management by reviewing documentation for accuracy and procedural compliance, releasing or rejecting documentation as appropriate, ensuring document and system elements are correctly identified and assembled for review and approval, and authoring or owning internal Document Control Department documents. Day-to-day responsibilities include serving as a focal point for document control and change control inquiries; coaching new Change Control Management Owners and Approvers; communicating change status and providing guidance to documentation personnel; maintaining facility employee signature files, Redbooks, document filing and archives; administering Iron Mountain/Records 365; assigning document numbers; generating manufacturing inspection checklists; supporting office supply requests and copier maintenance; and preparing, scanning, verifying, and archiving Device History Records. The role also provides backup and administrative support to other document personnel and the Documentation Clerk. The Documentation Associate provides backup support for the Change Control Governance Board (CCGB), including preparing meeting documentation, agendas, and minutes, and guiding Change Owners on CCGB meeting templates and non-routine change-control system or process functions. The role also supports internal and external audits, including ISO, CFR, Health Canada, MDSAP, and corporate audits, by responding to document and change-control requests, assembling and presenting requested information to auditors, and preparing ad hoc reports. This position is performed in an FDA-regulated manufacturing environment. Employees in designated work areas must wear a static protective smock and personal protective equipment (PPE), work in close proximity to other employees, and work in a temperature- and humidity-controlled environment. The physical demands include sitting, standing, bending, stretching, walking throughout the workday, and lifting at least 25 pounds. The estimated annual base salary range is $60,600 to $82,500. The position may also be eligible for discretionary bonuses. Baxter offers eligible employees medical and dental coverage beginning on day one, insurance coverage, retirement and financial benefits, educational assistance, time-off benefits, commuting benefits, employee discounts, employee assistance, and childcare benefits. Applicants must be authorized to work for any U.S. employer; visa sponsorship is unavailable for this position.

Requirements

High school diploma or equivalent.
Two or more years of experience with Product Data Management or documentation systems, or equivalent change control systems.
Proficiency with computers and Microsoft Office Suite.
Experience in document, data, and product configuration management, including change control.
Strong verbal and written communication and problem-solving skills.
Strong attention to detail and ability to independently organize workload, meet strict deadlines, and manage changing priorities with minimal supervision.
Ability to handle multiple tasks concurrently.
Ability to communicate with all levels within the organization.
Ability to respond to customer needs within the scope of the job.
Knowledge of Food and Drug Administration (FDA) regulations and application of Good Manufacturing Practices.
Ability to sit, stand, bend, stretch, and walk throughout the workday.
Ability to lift at least 25 pounds.
Ability to work well under tight deadlines.
Authorization to work for any employer in the United States; visa sponsorship is not available.

Responsibilities

Review controlled documentation for accuracy and compliance with procedures and release or reject it as appropriate.
Ensure document and system elements are correctly identified, accurate, and assembled for review and approval.
Author or own internal documents related to the Document Control Department.
Serve as a focal point for document control and change control processes, procedures, issues, and inquiries.
Coach new Change Control Management Owners and Approvers.
Communicate change status to originators and provide guidance to alternate documentation personnel.
Provide backup support for other document personnel and guidance and backup to the Documentation Clerk.
Maintain Facility Employee Signature Files and Redbooks.
Serve as the Iron Mountain/Records 365 Administrator and subject matter expert, managing and maintaining archival records.
Assign document numbers and generate Inspection Checklists for Manufacturing.
Maintain document filing and archiving.
Submit office supply purchase requests and provide administrative support, including handling document requests and copier maintenance.
Prepare, scan, verify, and archive Device History Records (DHRs).
Prepare documentation, agendas, and minutes for Change Control Governance Board (CCGB) meetings.
Guide Change Owners in completing the CCGB initial meeting template and using non-routine Change Control system or process functions, including Change Amendments, Change Plan Amendments, and Holds.
Support internal and external audits, including ISO, CFR, Health Canada, MDSAP, and corporate audits.
Respond to audit-related Change Control and Document Control requests, assemble requested materials, and present information to auditors.
Prepare ad hoc reports for planned internal and external audits as requested by management.
Participate in project and process improvement teams as needed.
Perform other duties as assigned.

Benefits

Medical coverage starting on day one
Dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
Potential eligibility for discretionary bonuses