US ~ Boothwyn, PA
GMP Operator - Clinical
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
Limited, as given by the Manufacturing Supervisor
EDUCATION and/or EXPERIENCE
Qualifications include HS diploma (or GED) with more than 2-5 years’ experience of GMP manufacturing and/or equipment maintenance/calibrations.
- 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.
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
- Proficient in the use of a calculator
- 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
- 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.