GMP Operator III

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.

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

We have an excellent career opportunity for a GMP Operator III to join our team in Philadelphia.

You will be responsible for carrying out the manufacturing of drug product while following all applicable SOP's, Batch Records and maintaining a cGMP environment. Complying and adhering to Good Manufacturing Practice (GMP) standards.

Main tasks and responsibilities

• Weighting and manufacturing of GMP, R&D, clinical and commercial batches (i.e dispensing, granulation, drying, milling, blending, compression, encapsulation, and bulk packaging operations)
• Set-up, operate, break down, clean, and sanitize equipment and production rooms as per SOP's, protocols and any provided trainings.
• Performance verification/ calibration of instruments
• Material handling
• Training and mentoring new and current GMP associates
• Submit all Samples to either quality control or analytical for testing or archiving as needed.
• Assure manufacturing department is always neat and clean by end of shift.
• Participates in process and cleaning validation activities as required.
• Notify the GMP Coordinator or Manufacturing Housekeeper as needed to ensure supplies are kept in stock and not lapse.
• Obtain any Intermediates, Raw materials or Empty drums and ensure anything brought into the MFG Airlock(s) are wiped down and free of all contaminates.
• Execution of GMP, R&D and clinical batch records with minimal or no supervision
• Authors and reviews GMP equipment standard operation procedures (SOPs)
• Proficient in batch record review

Additional Tasks/Responsibilities

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

Qualifications and experience required for competent performance

• The ideal candidate will have a HS diploma (GED) with some experience of GMP manufacturing or equipment maintenance/ calibration is preferred

• Competent in the use of Microsoft Office packages including Word, Excel, and windows operating systems.
• Experience and knowledge of cleaning within a GMP regulated environment/ department is required
• Preferable experience of working in a pharmaceutical analytical/ manufacturing environment or equivalent experience in another role.
• Read and interpret documents such as safety rules, equipment operating and maintenance instructions, and standard operating procedures and MSDS
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical solutions
  • Proficient in the use of a calculator, ability to work independently in a diverse and fast paced environment
  • Define problems, collect data, establish facts, and draw valid conclusions, good decision-making skills and ability to Multi-task.
  • Spatial management
    • Organization skills
  • Ability to interpret and carry-out instructions, Maintains a Professional appearance, demeanour
  • Ability to lift, push or pull 50 lbs at a minimum

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 the job:
  • While performing the duties of this job, the employees is frequently required to stand, walk, use hands to finder, handle or feel, smell, and talk or hear.
  • Employee should be able to pull equipment for cleaning
  • Employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel and crouch
  • 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 organization 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 organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, 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
• Employment Indicator Trainee

Apply Now

---