Associate, Documentation

Zvh; United States; On-site; USD 61,000 - 83,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid holidays

Paid time off

Employee stock purchase plan

Employee discounts

Job summary

Baxter is seeking a Documentation Associate I to support document and change control activities, ensuring accurate product and system releases. You will review, process, and file controlled documents while assisting audits and process improvements across the documentation function.

The role covers administration of Iron Mountain/Records 365, training, and backup support for the Documentation Clerk, in a manufacturing FDA-regulated setting.

Qualifications

• Experience with Product Data Management or documentation systems.
• Knowledge of FDA regulations and GMP.
• Able to maintain documentation accuracy and regulatory compliance.
• Strong attention to detail and organizational skills.
• Ability to work under deadlines and manage multiple tasks.

Responsibilities

• Assist with document and change control activities to ensure timely product releases.
• Review documentation for accuracy and compliance; release or reject as appropriate.
• Serve as focal point for document control and change control processes.

Skills

Document control

Data management

Change control

Verbal & written communication

Microsoft Office

Attention to detail

Time management

Education

High school diploma or equivalent

Tools

FDA regulations

ISO/CFR knowledge

Job description

This is where your work makes a difference. At Baxter, we believe every person -regardless of who they are or where they are from- deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Your Role

The Documentation Associate I provides support for document and change control activities to help ensure accurate and timely product and system releases. This role assists with reviewing, processing, maintaining, and filing controlled documents according to established procedures. The Documentation Associate I 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. This position is responsible for managing Iron Mountain/Records 365 archival and assisting other Document personnel as necessary.

What You’ll Be Doing

• Document Configuration & Product Data Management
• Review documentation for accuracy and compliance with procedures; release or reject as appropriate.
• Ensure all document and system elements are correctly identified, accurate, and assembled for review and approval.
• Author/Own internal documents as related to the Document Control Department.

Day-to-Day Support & SME Responsibilities

• Serve as a focal point for document control, change control processes/procedures, issues, or inquiries.
• Provide coaching for 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.
• Maintain Facility Employee Signature Files.
• Serve as the Iron Mountain/Records 365 Administrator/SME.
• Manage/maintain Redbooks.
• Document Number Assignment.
• Generate Inspection Checklist (ICL) for Manufacturing.
• Maintain Document Filing and Archiving.
• Office Supply Purchase Requests.
• Provide administrative and other support such as document requests and copier maintenance.
• Provide guidance and backup to the Documentation Clerk.
• Preparation, Scanning, Verification and Archival of Device History Records (DHRs).
• Perform other duties as assigned.

Change Control Governance Board (CCGB) Backup Support

• Prepare documentation, agendas, and minutes for CCGB meetings.
• Provide guidance to Change Owners on completing the CCGB initial meeting template and non-routine Change Control system/process functionalities (e.g., Change Amendments, Change Plan Amendments, Holds).

Audit Support

• Support internal and external audits, including ISO, CFR, Health Canada, MDSAP, and corporate audits.
• Assist with Change Control and Document Control requests during audits, including assembling Document Control/Change Control requests and presenting information to auditors.
• Prepare ad hoc reports (as requested by management) for planned internal/external audits.

What You’ll Bring

• High school diploma or equivalent required.
• Two (2) or more years’ experience with Product Data Management / documentation systems or equivalent change control systems.
• Undefined
• Proficient with computers and in the use of Microsoft Office Suite.
• Experienced in document, data, and product configuration management, including change control.
• Strong verbal / written communication and problem-solving skills.
• Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision.
• Ability to handle multiple tasks concurrently.
• Ability to communicate with all levels within the organization.
• Able to demonstrate responsiveness to customer needs, within job scope.
• Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices.

PHYSICAL DEMANDS

Must be able to sit, stand, bend, stretch and walk throughout the workday. Must be able to lift at least 25 lbs. Work well under tight deadlines.

WORK ENVIRONMENT

This is a manufacturing environment regulated by Food & Drug Administration (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: Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas. Work in close proximity to other employees. Work in an environment that is temperature and humidity controlled.

Compensation and Benefits

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $60,600.00 - $82,500.00 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

US Benefits at Baxter (except for Puerto Rico)

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we are determined to make a lasting impact as we redefine healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.