Document Control Specialist I (Temp-To-Hire)

GROW WITH US :

If the following job requirements and experience match your skills, please ensure you apply promptly.

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience.

We’d love for you to team up with us to innovate every day, put people first, and take a no-shortcuts approach that has propelled us to become a leader in the diabetes technology industry.

A DAY IN THE LIFE :

• Processes documentation initiation and change requests through the Electronic Documentation Management Systems (EDMS).
• Maintains Device History Records, Device Master Records, and other logs applicable to the Quality System.
• Ensures that all records related to the Document Control area are filed appropriately and easily retrievable in the document center and other storage locations.
• Archives / retrieves obsolete versions of documents.
• Prepares process and status reports.
• Performs periodic audits of documents and records to ensure accuracy.
• Reviews approved documents for accurate format, signatures, dating and Good Documentation Practices.
• Ensures work is performed in compliance with company policies including Privacy / HIPAA and other regulatory, legal, and safety requirements.
• Other duties as assigned.

YOU’RE AWESOME AT :

1. Knowledge, skills & abilities :

• Able to effectively share information and ideas within and outside of department in written or verbal form; able to put forth own ideas and gain understanding from others.
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Demonstrated ability to schedule and coordinate project priorities and resources and to produce high quality work.
• Experience working with an EDMS, preferably Agile.
• Knowledge of Adobe Acrobat and MS Office including Word, PowerPoint, Excel, Visio, Outlook.
• Knowledge of Solid Works preferred.
• Knowledge of Enterprise Resource Planning and Materials Resource Planning databases preferred.

2. Minimum certifications / educational level :

Bachelor's degree or equivalent combination of education and applicable work experience.

3. Minimum experience :

• 1 plus years experience preferably within an FDA regulated industry including :
• Experience in medical device or other GMP-regulated industry.
• Experience with quality system documentation and good documentation practices.

WHAT’S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people.

Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too.

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table.

But sometimes we forget that when we don’t meet 100% of a job description’s criteria maybe you’re feeling that way right now?

We encourage you to apply anyway. Because we want you to be you, with us.

COMPENSATION :

The starting base pay range for this position is $26.00 - $34.00 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market.

YOU SHOULD KNOW :

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations.

A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and / or confidential information, including customer protected health information.

This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

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