Ref No.

DS-QA-2018

Location

US ~ Boothwyn, PA

Documentation Specialist

Company Overview

Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

The Role

Due to growth and expansion, we have an exciting opportunity for a Documentation Specialist to join the Quality Assurance Group.  As a Documentation Specialist, you will be responsible for processing and archiving documents according to regulatory standards.

Other tasks and responsibilities will include:

Maintaining a document index to track the status and location of paper documents and records.

Managing manufacturing and laboratory records throughout their lifecycle.This includes generating, issuing, archiving and retrieving the records.

Controlling access to archived records.

Providing training to personnel on the documentation process.

Ensuring compliance of the GMP documentation process.

Working with Project Managers to meet the established timelines for product realization.

Communicating with Clients regarding document processing statuses.

Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, DOT, OSHA and DEA.Comply with all company and site policies and procedures.

Remain current in profession and industry trends.

Make a positive contribution as demonstrated by:

Make suggestions for improvement. Implement changes as needed.

Work as part of a team

Learn new skills, procedures and processes.

Be available for other duties as required.

Be available for overtime as needed.

 

The Candidate

The successful candidate will have bachelor’s degree or equivalent coupled with 0 to 3 years of experience in pharmaceutical document control.  Experience with electronic documentation management systems is a plus.

 

Other essential skills and experience are:

The candidate must possess good organizational skills to organize the information, data, documents and reports. Must be able to multitask and work on various documents during a given period of time.
Successfully completes regulatory and job training requirements.
Proficient in Word, Excel and Outlook at a minimum.
Ability to work with others in a team environment.
Ability to work with little supervision.
Attention to details.

 

Company benefits:

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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