Ref No.

DS-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, specializing 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.

 

GENERAL PURPOSE OF JOB

Responsible for maintaining control and distribution of GMP documents, media, and SOPs. Maintains systems for physical and electronic document storage, retrieval, and archives.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned as appropriate.

  • Responsible for overall coordination of controlled documentation within the company
  • Maintains document list and issues new document numbers.
  • Creates and maintains records for issuing and archiving media, such as Log books and Lab Notebooks.
  • Maintains inventory records of archived and offsite documents and media.
  • Controls access to all documents, media, and SOPs.
  • Processes all incoming and outgoing documents for
  • Computer entry
  • Scanning
  • Filing
  • Distribution
  • Archiving
  • Facilitates the routing of documentation to and from clients, ensuring completeness and accuracy while managing priorities and escalations.
  • Adherence to procedures for maintaining client confidentiality.
  • Maintains current client contact list.
  • Follows up with clients on document status.
  • Process SOPs by scanning, filing, and uploading into the SOP Viewing System.
  • Assists Quality Assurance with documentation as needed.  Acts as other back up for other administrative functions on as needed basis.
  • Assist Department supervisors with other activities as directed. These activities may include cross functional needs.

 

ADDITIONAL POSITION REQUIREMENTS

  • Complies with all company and site policies and procedures.
  • Remains current in profession and industry trends.
  • Makes a positive contribution as demonstrated by:
  • Making suggestions for improvements
  • Learning new skills, procedures and processes
  • Is available for other duties as required.
  • Is available for overtime as needed.

 

SUPERVISORY RESPONSIBILITIES

None

 

QUALIFICATIONS 

EDUCATION and/or EXPERIENCE

High School Diploma with 0-2 years of experience.

 

LANGUAGE SKILLS

  • Read and interpret documents such as safety rules, operating and maintenance, instructions, and standard operating procedures.
  • Write business correspondences.
  • Review and revise standard operating procedures related to Documentation.

 

MATHEMATICAL SKILLS

  • Work with basic mathematical concepts.
  • Apply mathematical operations to such tasks as directed.

 

REASONING ABILITY

Define problems, collect data, establish facts and draw valid conclusions.

 

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

  • Familiar with a variety of office equipment.
  • Successfully completes regulatory and job training requirements.
  • Computer skills:
  • Enter data into computer using software applications for data entry and word processing
  • Work and be proficient with e-mail systems
  • Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
  • Ability to perform under stress in cases of emergency, critical or hazardous situations.
  • Ability to work with others in a team environment.

 

PHYSICAL DEMANDS 

  • While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.
  • The employee is occasionally required to sit and reach with hands and arms.
  • The employee must occasionally lift and/or move up to 10 pounds.
  • Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

 

Ask us a question