Documentation Specialist

Job Description

Documentation Specialist

On-Site in Canton, MA

6 Month Contract (Potential Extensions)

What You Will Achieve:

The QS Documentation Specialist II supports the documentation activities in support of product production and release. The position has a great deal of interaction with many other departments, including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory and Logistics. The primary responsibilities are SmartSolve Document Management routing and approval, ensuring security and easy retrieval of the controlled files, batch record issue and supporting production needs.

Perform SmartSolve Document Management routing, review, and approval activities. Issue training Packets, as needed.

Maintain databases for Document Control room inventory

Control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams

Responsible for filing and maintaining archived documents.

Responsible for assisting with the destruction of documents that are outside of the required retention period and/or assisting with the preparation of records for storage offsite

Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods

Review Facilities documentation for compliance prior to filing in the Equipment History Files.

Communicate any areas of deficiency to the responsible individuals

Maintaining the cell bank database in Excel by entering new binders into inventory and tracking the hard copies taken for reference.

What You Need to Achieve It:

· Requires Associate’s Degree or equivalent

· 3 - 5 years of related experience in a GMP/GLP regulated environment

· Documentation experience required

Company Description

Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.

Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.