Ref No.

SGO1-2018

Location

US ~ Boothwyn, PA

Senior GMP Operator

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

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

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 POSITION REQUIREMENTS

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

 

SUPERVISORY RESPONSIBILITIES

Limited, as given by the Manufacturing Supervisor

 

QUALIFICATIONS 

EDUCATION and/or EXPERIENCE

Qualifications include HS diploma (or GED) with at least 4 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 OR 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.

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