Senior Document Control Specialist in Portage, MI at Stryker Corporation

Date Posted: 6/25/2019

Job Snapshot

Job Description

Who we want

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. 
  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 

What you will do

Would you like to work with all divisions of Stryker on a regular basis without the hassles of traveling? As a Senior Document Control Specialist, you will work with Global Process Owners (GPOs) and other Regulatory and Clinical Affairs professionals to support the organization as you develop, modify, and execute processes and procedures. The Senior Document Control Specialist is responsible for managing the external standard notification process and ensuring Corporate and regulatory compliance of the Corporate Quality System Documents and associated processes.  They are also responsible for accurate review and processing of documentation. Responsibilities may include:

  • Assist in the management of Corporate GMP document and data additions and modifications
    • Assist authors with the creation and revision of Corporate quality documents
    • Ensure proper template usage and formatting
    • Manage document review, comment, and approval processes
    • Ensure proper form completion
    • Management and troubleshooting of documentation workflows
    • Management of documentation of divisional and other site implementations, delays, and exclusions
    • Ensure training is assigned as specified during the document approval process
    • Manage Stryker Corporate document management system access and removal requests
    • Troubleshoot and execute system test scripts
    • Provide training support as needed and/or requested
    • Act as CAII in onePLM
    • Manage Corporate Quality records
  • Write, format and edit documents, including Standard Operating Procedures, Specifications, Forms, and Policies that support GMP operations to ensure compliance with cGMP and FDA guidelines and with additional quality standards addressed in Stryker’s Quality Manual
  • Provide support for the maintenance of the Stryker Corporation Quality and Regulatory Master Glossary
  • Provide support for the maintenance of the Corporate Quality Document Control style guide
  • Develop and support implementation of improved business processes including creating and revising procedures and workflows
  • Ensure adherence to the Standard Operating Procedures that govern the Stryker Corporate document management system
  • Provide input and support for managing corporate documentation schedules, documentation issues, etc.
  • Perform other related duties and special projects as required or requested.
  • Monitor and manage external standards

What you need

  • Bachelor’s degree required. Major in technical writing, journalism, communications or English preferred
  • 2+ years experience with standards management, document control and records management
  • Experience working in a regulated environment and in electronic systems process flows, validation, and approval
  • Demonstrated written fluency in English
  • Strong critical thinking skills
  • Strong accuracy and strict attention to detail
  • In-depth knowledge of and proficiency with Microsoft Office Suite
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • Passion for quality and procedural compliance

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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