Information Specialist

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Opportunity:

As an information Specialist, you will support production, business, and other processes in a team-based manufacturing environment. You will prepare, revise, and route documentation in compliance with regulations and standards (e.g., Quality System Regulations, Content Approval, ISO Standards, and internal guidelines).

Job Facts:

• Prepares and/or revises and controls departmental documentation in compliance with department, Roche standards, and regulatory requirements. Implements, administers, and coordinates the change process following correct procedures and compliance (i.e. ISO, policy, department standard, configuration documentation, change management). Partners with other internal departments and areas (i.e. configuration management, quality) as necessary.

• Administers related systems (i.e. Windchill, SAP, CN, Configuration Management) and databases. Sets up permissions, and may create new workflows and document types...

• Administers and maintains procedures to ensure quality and accuracy by preparing and reviewing the materials for completeness and coordinating the review/sign-off process to expedite implementation. May provide direction to administrative support staff.

• Monitor reports to ensure documents (and workflows, if appropriate) are approved on time. Assist in tracking metrics to ensure the process is efficient, effective, and compliant. Effectively communicate process improvement opportunities to approval areas, content owners, and the content approval team.

• May provide training/communication as necessary on documents and associated changes.

• Leads process improvement initiatives and other departmental projects as assigned. Analyze the effect on processes as a member of cross-functional teams and recommend appropriate business process changes by evaluating multiple alternatives.

• Ensure established programs continue to be best practices. Solicit feedback from others to improve current processes.

• Participate in special projects as requested

Who You Are:

• High school diploma (or equivalent experience).

• 2 - 5 years of experience in document management.

• Prior experience with document control systems or the ability to learn and effectively utilize such systems (Windchill, DiaDoc, SAP, and CN system).

• Understanding the regulations governing the medical device industry and the policies needed for effective change control.

• Experience with word processing, database management, and spreadsheet development.

• Strong organization and planning skills.

• Ability to handle multiple functions at one time.

• Practical oral and written communication skills.

Preferred Qualifications:

• Solid computer skills (Google and MS Office).

• Excellent communication and organization skills

• Demonstrated experience revising training materials and content.

• Familiarity with adherence to brand standards, creating instructor-led training modules, job aids, online tutorials, and other training materials.

• Understanding of quality system regulations and ISO standards.

• Knowledge of training practices, principles and methods.

• Understanding of quality system regulations and ISO standards

• Requires a high school diploma (or equivalent experience)

• Prior experience with document control systems or the ability to learn and effectively utilize such systems (Windchill, DiaDoc, SAP, and CN system).

• Understanding of the regulations that govern the medical device industry and the policies needed for effective change control.

• Experience with word processing, database management, and spreadsheet development.

• Strong organization and planning skills

• Ability to handle multiple functions at one time. Efficient and effective oral and written communication skills

Relocation benefits are not available for this job posting.

The expected salary range for this position, based on the primary location of Indiana, is 52,500.00 - 97,500.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.