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GMP Operator (2nd Shift)

Quotient Sciences

Quotient Sciences

Boothwyn, PA, USA
Posted on Friday, May 17, 2024

GMP Operator (2nd Shift)

Boothwyn, PA, USA Req #194
16 May 2024
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,
fast. Because humanity needs solutions, fast.

The Role

GMP operations in the daily execution of Manufacturing GMP, and Clinical batches; cleaning/sanitization procedures and support functions of equipment, facilities and instruments.

Main tasks and responsibilities will include:

  • Facility Sanitization & Equipment Cleaning Procedures
  • Weighing and Manufacturing of GMP, R&D and Clinical Batches
  • Equipment Staging, Setup, Operation, Disassembly and Cleaning with no supervision
  • Performance Verification/Calibration of Instruments
  • Material Handling
  • Training and Mentoring New and Current GMP Associates
  • Execution of GMP, R&D and Clinical batch records with minimal or no supervision
  • Authors and reviews GMP equipment Standard Operating Procedures (SOPs)
  • Proficient in Batch Record Review

Additional responsibilities include:

  • 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 procedures.
  • Makes a positive contribution as demonstrated by:
  • Making suggestions for improvement
  • Providing overtime as needed
  • Learning new skills, procedures and processes.
  • Is available for other duties as required

The Candidate

  • Qualifications include HS diploma (or GED) with more than 2-5 years’ experience of GMP manufacturing and/or equipment maintenance/calibrations.

Language Skills

  • Read and interpret documents such as safety rules, equipment operating and maintenance instructions, and standard operating procedure & MSDS
  • Write internal business correspondence and standard operating procedures.

Mathematical Skills

  • Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
  • Proficient in the use of a calculator

Reasoning Ability

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

Other Skills, Abilities, Qualifications

  • Organizational skills.
  • Computer skills:
  • Familiarity with Microsoft Office Suite
  • Windows Operating System
  • Demonstrates Mechanical Aptitude
  • Ability to work with others in a team environment.
  • Ability to work with minimal supervision
  • Attention to detail

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, 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.

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

Other details

  • Pay Type Hourly