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PM/Calibration Coordinator - Nypro Healthcare at Nypro Inc.

Posted in Admin - Clerical 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Maple Grove, Minnesota





Job Description:

At Jabil, we empower the brands who empower the world – it’s our reason for being and the guiding force that’s driving us to become the most technologically advanced manufacturing solutions provider on the planet.  Whether we’re serving one of the world’s biggest and best known brands or the coolest tech startups, our resolve never wavers. We share common desires with these brands: to make the world a better, safer and cleaner place.

ABOUT OUR COMPANY

Nypro Healthcare, a Jabil company, offers healthcare and pharmaceutical customers the widest array of design and manufacturing capabilities in the industry. With more than 40 years of experience, our highly specialized teams meet the complex and regulated demands of the diagnostics, medical devices and pharmaceutical markets enabling the world's leading brands to fulfill their market potential. Nypro Healthcare’s customer focused services range from ideation to device development support, engineering, supply chain optimization, vertical plastics and electronics to device assembly operations, all at our purpose-built facilities that support stringent healthcare requirements and protect our customers’ intellectual property.

JOB SUMMARY

The Document Control Coordinator is responsible for supporting the maintenance of the pm/calibration document management system for recordings and filings and coordinating overall document control processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES


  • Maintains working knowledge of applicable regulatory requirements


  • Participates in internal audits and external regulatory inspections

  • Participates in the training of colleagues on the requirements surrounding pm/calibration documentation and records management

  • Communicates best practices to staff during department meetings and assists in group training as directed by Manager

  • Performs analysis of data (monthly metrics), as requested by Senior Management

  • Write, review and update SOPs relating to documentation collection and storage

  • Ensures documentation is current and available for use

  • Manages references standards database to ensure accuracy

  • Receives and Coordinates external customer documentation

  • Oversees long-term storage of information and data protection and reports to Management

  • Acts as point of contact for retrieval of specific documentation, as required

  • Assists with file migrations and performing audits to ensure accuracy

  • Coordinates records management activities between plant sites to ensure effective and efficient compliance with all applicable laws and regulations

  • Reviews and maintains records retention schedules; and participates in maintaining compliance to Corporate and Site document and records management programs, systems and procedures

  • Maintains and updates logs and/or databases used for tracking records

  • Supervises the use and requirements for all inactive hardcopy record storage activities

  • Provides site assistance when implementing legal holds in effective storage inventory and releases

  • Maintains controls over retrieval integrity of offsite storage

JOB QUALIFICATIONS

KNOWLEDGE REQUIREMENTS


  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

  • Ability to define problems, collect data, establish facts, and draw valid conclusions

  • Ability to operate a personal computer including using a Windows based operating system and related software

  • Advanced PC skills, including training and knowledge of Jabil’s software packages

  • Ability to write simple correspondence.  Read and understand visual aid

  • Ability to apply common sense understanding to carry out simple one- or two-step instructions

  • Ability to deal with standardized situations with only occasional or no variables

  • Ability to read and comprehend simple instructions, short correspondence, and memos 

  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals 

  • Ability to compute rate, ratio, and percent and to draw and interpret graphs

EDUCATION & EXPERIENCE REQUIREMENTS


  • Typically requires a minimum of 4-6 years experience in a similar role (preferably in an engineering or QA/QC environment) and displays team leadership skills


  • Or an equivalent combination of education, training or experience

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.