Documentation Specialist, Smithers Viscient LLC, Wareham, MA

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 year 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

Online Application Address:

www.smithersviscient.com/careers