Document Control Specialist

hace 3 semanas

Tijuana, México Insulet Corporation A tiempo completo

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
- We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on itPosition Overview:
The Document Control Specialist will work under the guidance of the Quality Document Control Manager to ensure control, security, integrity, and availability of documentation to site personnel. This person is part of the team responsible for maintaining document control and record retention globally. This person is responsible for control of documents and coordination of controlled documents related activities globally in pursuant to all applicable regulations.

**Responsibilities**:

- Review and Approve Change Orders in PLM
- Perform Coordinator Role in Veeva
- Review all Documentation
- Create and update documentation master files
- Create and Maintain Item Masters and Bill of Materials in ERP system
- Filing and other organizational tasks
- Maintain supplier data in PLM
- Perform User Administration in PLM System & Veeva
- Data Entry
- Record retention
- Maintain/Retrieve historical paper documentation from offsite storage facility
- Perform PLM and Document Systems training
- Performs other duties as required

Education and Experience:
Minimum Requirements:

- 2-4 years’ experience maintaining documents within a QC or GMP/ISO-certified environment preferred, or more than 2 years’ experience with Quality, Records management and/or equivalent combination of education and experience, and other special skills if required

Preferred Skills and Competencies:

- Demonstrated knowledge of Microsoft Office, including Access.
- Expert knowledge of Microsoft Word.
- Knowledge of Configuration Data Management requirements for engineering documentation a plus, however, is not required.
- Working knowledge of documentation functions of a medical device company preferred.
- Familiarity with ERP (e.g. MFG/Pro) is a plus, however, is not required.
- Effective written and verbal communication skills.
- Ability to communicate at all organizational levels.
- Ability to organize and judge priorities.
- Ability to generate and maintain accurate records.
- Comfortable communicating to all levels and functions.
- Must have strong clerical skills (filing, alphabetization, etc.).
- Very strong organizational skills.
- Very strong attention to detail.
- Able to work in a team environment

Physical Requirements (if applicable):

- None

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote #LI-AS1

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