Documentation Technician II
M-F 8-4:30
Position Summary
This position supports the operational activities of the site through tasks associated with creation and maintenance of quality documentation. These activities are based on written procedural requirements established both locally and at higher corporate authority.
Create, coordinate, implement, and archive Plant Change Orders, Standard Operating Procedures (SOPs), Batch Records (Work Orders), etc. Maintain critical quality documentation related to Change Control, Validation system, including Installation Qualification and Operational Validations, and Engineering Change Requests. Coordinate and implement all policies, procedures, and specifications received from Corporate that are applicable to the Austin Plant. Maintain Documentation administration requirements related to all aspects of record management.
Essential Duties & Responsibilities
- Review and coordinate the creation, edit, and routing of change orders for new and revised Standard Operating Procedures, Work Instructions, Batch Records, etc. as requested for the Austin and Round Rock manufacturing sites.
- Create and issue Batch Record packages, using the Document Management System (DMS), to all appropriate operational areas within the Austin and Round Rock manufacturing sites, based on the plant manufacturing schedule(s).
- Maintain the documentation library including the issue, receipt and tracking of validation packages, batch records, logbooks, etc. maintained in the Documentation Storage Room.
- Perform administrative review of validation packages to ensure compliance with local SOPs.
- Perform administrative review of simple change orders / documents within the plant document management system to ensure compliance with local SOPs.
- Communicate with change initiators to ensure item content and the contents of the change package are correct and accurate.
- Perform administrative review of change control requests and track linkage to the documentation and validation changes.
- Adhere to cGMP’s, SOPs and plant policies / procedures.
- Actively participates in problem solving tasks that involve interaction with all plant disciplines.
- Ensures the timely creation and delivery of appropriate documents including schedule change requests and manufacturing, laboratory, and manufacturing quality work order requests.
- Implement approved change orders / documents within the plant document management system.
- Responsible for coordinating the logbook management process.
- Responsible for the receipt, review and distribution of all new and revised corporate policies, procedures, and specifications.
- Coordinate the biennial review process for controlled documents.
- Coordinates records management activities related to local and off-site storage of documents.
- Once established, may act as a Qualified Fellow Employee (QFE) or cross-train other individuals in their area of focus.
- Participate in department process improvement projects.
- Assist with the writing of Standard Operating Procedures.
- Perform other related duties as assigned or required.
Knowledge & Skills
- Demonstrated skills on a personal computer using word processing, spreadsheet, and/or database software as well as standard business communication tools such as Microsoft Outlook, etc.
- Must be able to prioritize and manage a high volume of complex activities; priorities may change rapidly and/or unexpectedly.
- Must have excellent written and verbal English communication skills.
- Must be detail oriented, and able to pay close attention during comparison of details in multi-page documents while addressing urgent customer needs that may result in interruptions.
- Must be able to think critically and analyze information objectively.
- Demonstrated teams participation with leadership behaviors preferred.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Associates degree from an accredited college or university is required
- 1 year of applicable experience is required
- In lieu of the Associates degree requirement above, a High School Diploma with 3 or more years of experience in a quality or production related role in a GMP environment is required.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- This is a customer – focused role requiring flexibility and includes a willingness to shift or extend scheduled hours on short notice to meet customer needs.
- This position requires the individual to make quality judgments and decisions based on written procedures outlining the requirements for acceptable quality documentation. Decisions made by an individual in this position can and will affect the quality of documentation used in the manufacture of product and governing local quality systems.
- Must be able to occasionally move and lift objects of up to 25 pounds
- Typically requires travel less than 5% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Compliance
Primary Location
US-TX-Austin
Schedule
Full-time
Shift
Day Job
