Randstad Documentation Control Specialist in Holliston, Massachusetts

Documentation Control Specialist

job details:

  • location:Holliston, MA

  • salary:$50,000 - $58,000 per year

  • date posted:Friday, November 9, 2018

  • experience:1 years

  • job type:Permanent

  • industry:Miscellaneous Manufacturing Industries

  • reference:144611

job description

Documentation Control Specialist

Permanent position: An Entry-Level Quality Assurance Documentation Specialist is needed for a full time position at a leading medical device manufacturer in the Holliston, MA area. The ideal candidate will have their Bachelors Degree and at least 1 year of experience working within an FDA-regulated environment (Med Device, Pharma, etc.). Must have experience using eQMS, ERP or other equivalent system, as well as working knowledge of Good Documentation Practices (GDP). CFR, ISO 13485 and 14971 knowledge is preferred. Apply now for immediate consideration!

Responsibilities for the Documentation Control Specialist

  • Performing documentation related activities for the facility such as: incoming inspection records, batch records, shipping documentation, equipment and maintenance documentation, and other logs and forms

  • Performing status labeling of raw materials and finished products

  • Assisting with filling and retrieval of documents (both physical and electronic) within the Document Control center

  • Participating in non-conformance, deviation, or complaint investigations

  • Revising, reviewing, or approving controlled documents

  • Supporting verification of any critical inspections or tests as needed in relating to incoming, production, and/or validation activities

Requirements for the Documentation Control Specialist

  • Bachelors Degree (Scientific or Analytical Discipline) preferred OR High School Diploma and 3+ years related experience

  • 1+ year experience working within an FDA-regulated environment (Medical Device, Pharma, etc.)

  • Experience using eQMS and ERP or equivalent paper based system

  • Working knowledge of GDP (Good Documentation Practices)

  • Knowledge of CFR (11, 803, 806, 809, 810, 820), as well as ISO 13485 and ISO 14971 is preferred

  • Strong attention to detail, excellent written and verbal communication skills, and ability to work well in a team environment


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.