Ref No.

FD-21-38

Location

US ~ Garnet Valley, PA

Assistant GMP Coordinator

Company Overview

Our growing and successful business comprises of over 800 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

  • Coordinate equipment, cleaning, maintenance related activities in the manufacturing area
  • Management of the GMP Custodian Group
  • To comply & adhere to Good Manufacturing Practice (GMP) standards.

Main tasks and responsibilities will include:

  • Assists in GMP area Housekeeping
  • Prepare the area ready for client audits or visitors
  • Assists in room or equipment cleaning schedule
  • Assists in coordination of Cleaning Verification activities/scheduling
    • Form preparation
    • Communication (with analytical team, cleaners and formulators)
  • Acts as caretaker of the GMP supplies and ordering
  • Maintains GMP equipment storage room
    • Ordering of spare parts
  • Submit Workorders and coordinates maintenance activities in the area
  • Take part in continuous improvement activities and highlight any improvements needed for equipment cleaning and storage
  • Tooling Coordinator back up
  • Assist in the training of personnel on
    • Use of Manufacturing
    • Logbook documentation
    • GMP Area Cleaning
    • Level I and II equipment cleaning
    • Batch Record Documentation

Additional tasks/responsibilities:

  • Carries out duties in compliance with all state and federal regulation and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
  • Makes a positive contribution as demonstrated by:
    • Making suggestions for improvement
    • Providing overtime as needed
    • Leaning new skills, procedures and processes
    • Is available for other duties as required

Job demands:

The job may involve the following:

  • Very high concentration of work
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Working in a hazardous environment with high requirement to follow safety procedures
  • Working outside normal working hours
  • Needing to respond to client demands
  • Physical demands of Job:
    • While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finder, handle or feel. Smell and talk or hear.
    • The employee should be able, pull equipment for cleaning.
    • The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel and crouch.
    • The employee must occasionally lift and/or move up to 50 pounds.
    • Must be able to qualify for respiratory protective equipment use.

 

The Candidate

  • High School Diploma or equivalent GED with good math qualifications.
  • cGMP area work experience preferred.
  • Knowledge of equipment handling and repairs
  • Experience and knowledge of cleaning within a GMP regulated environment/department is preferred.
  • 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 ability to take appropriate actions in cases of emergency, critical or hazardous situations.
  • Ability to work with others in a team environment.
  • Ability to work with little supervision
  • Attention to detail
  • Read and interpret documents such as safety rules, equipment operating and maintenance instructions, and standard operating procedures and MSDS
  • The ability to apply concepts such as fractions, percentages, rations and proportions to practical solutions
  • Proficient in the use of a calculator
  • Define problems, collect data, establish facts and draw valid conclusions.
  • Organizational skills

 

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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