Technician II, Document Control at ICU Medical, Inc. in Southington, Connecticut

Job Description:

Job Description



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 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 manufacturing site.
• Create and issue Batch Record packages, using the Document Management System (DMS), to all appropriate operational areas within the manufacturing site, 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

About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now