Document Control Specialist - Acton, MA (Hybrid) at Insulet in Acton, Massachusetts

Job Description:

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 it!

Job Title: Document Control Specialist

Department: Quality & Regulatory

FLSA Status: Non-Exempt

Position 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.

• Have a deep understanding of manufacturing document control process for a medical device manufacturing environment.

-Expert knowledge of Microsoft Word.

• Have an understanding of inventory dispositions and post implementation tasks.

-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

This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid

Additional Information:
The US base salary range for this full-time position is $26.25 - $39.45. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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