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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Document Coordinator

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #73152

Our client, a leading pharmaceutical company, is hiring a Document Coordinator on a contract basis.

Work Location

Devens, MA

Summary

1. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.

2. Manages the document change control process, coordinating cross functional reviews, approvals and effective dates in alignment with requirements (cGMP and client) and customer needs

3. Serves as a subject matter expert for the electronic document management system.

4. May assist in user training on the electronic document management system.

5. Provides Records Management support during in regulatory agency inspections and corporate audits.

 

Education and skills

• Minimum HS diploma with related experience required. B.S. degree (in Science, Engineering, Biochemistry) is preferred.

• A minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.

• Strong teamwork and communication skills and the ability to follow written and verbal instructions.

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.

• Familiarity with US and EU cGMP regulations and guidance is required.

• Working knowledge of common computer systems such as MS-Word and Excel is required.

• Experience with electronic document management systems, is preferred.

 

Must have’s:

• Experience in MS Office (Word, Excel, PowerPoint, etc.)

• Experience with Document Management systems, either manual or electronic. Electronic preferred.

• Experience archiving controlled / critical records.

• Experience in a regulated environment (Manufacturing, Food Industry, Medical Device

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