Documentation Specialist, Wareham, Massachusetts, United States

 

We are a member company of The Smithers Group, trusted providers of innovative solutions. Smithers Viscient performs environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer product industries. Smithers Viscient has performed standard guideline and higher-tiered environmental studies for over 45 years. We conduct studies to satisfy all regulatory requirements globally. Smithers Viscient is a leader delivering trusted testing services.

Offerings include environmental fate, plant and animal metabolism, aquatic and terrestrial ecotoxicology, honeybee and pollinator testing, avian toxicology, residue, analytical, and product chemistry, and regulatory risk assessment.  Contact us to apply or to learn more about a career at Smithers Viscient. 

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Documentation Specialist, Wareham, Massachusetts, United States

Posted: 09 October 2017

Job Summary

  • Responsible for providing comprehensive Records Management and Documentation support and guidance to departments requiring Records Storage and support. Ensures that archives and archived documentation meets our customer and regulatory requirements.
  • Serve as Lead Archivist and be able to independently plan and carry out special projects.
  • Responsible for performing, monitoring and maintaining tasks and responsibilities for Records Management and serve as single point of contact.
  • Monitor physical archive vault, control of contents and organization of documents within.
  • Develop, write and review Standard Operating Procedures when required.
  • When applicable, train staff on Records Management and Document Control processes and procedures.
  • Be active member of any 5S projects involving Records Management or Archives.
  • Will coordinate, prioritize, expedite and advise on copying/scanning of Records contained in Archives.
  • Manage transferal (archive to archive transfer) of raw data and specimens as applicable to customers or third party archiving facilities.
  • Accountable to take corrective actions/write Standard Operating Procedures deviations if needed.
  • Responsible for initiating annual revisions to laboratory notebooks/facility records.
  • Follows established safety and environmental guidelines and procedures for all work performed.
  • Report any non-compliance of GLP throughout all applicable areas and functions when observed.
  • Coordinate retrieval from archives and provide documentation for regulatory inspections as requested.
  • May be required to attend training sessions for personal development.
Qualifications
  • BS/BA in Life Science and 1 years experience; or Associate's degree and 2 years of experience
  • Minimum 1 year experience working with Document Control Systems or Records Management.
  • Prior experience in a biotech or pharmaceutical company preferred.
  • Advanced ability with various computer systems and experience using Microsoft Word and Electronic Document Management System (EDMS).
  • Operate office equipment such as a computer printer, fax machine, scanner.
  • Working knowledge of FDA requirements for GLP compliance.
  • Interaction across functional areas either by email, phone, or face-to-face.
  • Excellent written and verbal communication skills.
  • Commitment to quality and pride in work. Detail oriented.
  • Must be flexible; able to handle a moderate degree of stress, changes in priorities and frequent interruptions.
  • Maintain a high degree of confidentiality and professionalism.
  • Willingness to learn as required.
  • Work well with personnel at all levels of skill and authority throughout the company.
  • Must be able to complete assigned tasks independently with minimal instruction and have the initiative to obtain guidance on new assignments when needed.
  • Ability to remove road-block and develop solutions to complex issues. Be able to see End to End view.
  • Should be Highly Focused on Learning, and have a Continuous Improvement mindset

What makes Smithers Viscient a great place to work? Learn about how we make a global impact, and see an overview of employee benefits and perks.

To apply for this position, please send your CV to lobrien@smithers.com