Ref No.

FSF

Location

US ~ Boothwyn, PA

Lead GMP Operator - Commercial Manufacturing (2nd Shift)

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

  • Lead and Assist with daily Commercial GMP operations by timely execution of manufacturing schedules as directed by supervisor.
  • Provide detailed self-sufficient training to senior and junior GMP associates on procedures, equipment operation, troubleshooting and cleaning.

 

Essential Duties And Responsibilities

  • Manufacture of Commercial batches.
  • Adherence to Commercial manufacturing schedule and communication between shifts.
  • Support with proper batch record entries during batch execution.
  • Train Commercial GMP associates on batch record entries, equipment maintenance, log book entries, Equipment set up, trouble shooting and cleaning procedures.
  • Update SOPs to make them relevant and in line with the GMP practices.
  • Help Department set-up two fully functioning and independent commercial manufacturing lines in both first and second shift each in consultation with Director.
  • Support Commercial manufacturing as assigned.

 Additional Position Requirements

  • Assist in the execution of manufacturing batch records and material sampling.
  • Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedure.
  • Makes continuous positive contribution as demonstrated by:
  • Making suggestions for improvement
  • Providing overtime as needed
  • Motivate GMP associates in both shifts as needed.
  • Is available for other duties as required.

Supervisory Responsibilities

  • Yes
  • Senior GMP Operations Associate (Both shifts). This responsibility could change as the department expands and changes based on work load.

 

Qualifications

  • HS diploma (or GED) with more than 5 years of GMP manufacturing experience.

 Language Skills

  • Read and interpret documents such as safety rules, equipment operating and maintenance instructions and standard operating procedures.

Mathematical Skills

  • Comfortable with equations, and general mathematical calculations.
  • Proficient in using a calculator
  • Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.

Reasoning Ability

  • Management of GMP area and personnel.
  • Define problems, collect data, establish facts and draw valid conclusions.

 Other Skills, Abilities, or Qualifications

  • Organizational skills
  • Computer Skills such as MS office suite and Windows operating system.
  • Clear Communication skill (Verbal and written).
  • Ability to work with team.
  • Attention to details
  • Ability to work with minimal supervision
  • Communication to management and subordinates.

 Physical Demands

  • While performing the duties of this job, the employee is frequently required to stand, walk and use hands.
  • The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel and crouch.
  • Capable of carrying or moving items not more than 50 lbs.
  • Must be able to qualify for respiratory protective equipment use.

 

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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