GMP Custodian

Quotient Sciences Limited; Philadelphia (Philadelphia County); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a dedicated GMP Custodian to join their team in Boothwyn, Philadelphia. In this pivotal role, you will lead the execution of cleaning and sanitization procedures, ensuring compliance with Good Manufacturing Practice (GMP) standards. Your efforts will directly contribute to the efficiency of drug development processes, helping to bring vital solutions to patients faster. If you have a passion for maintaining high standards in a dynamic environment and want to make a tangible impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• HS diploma required; experience in GMP manufacturing preferred.
• Competent in Microsoft Office and cleaning in GMP environments.

Responsibilities

• Lead cleaning and sanitization procedures adhering to GMP standards.
• Train personnel and ensure availability of GMP supplies.

Skills

GMP Standards

Cleaning Procedures

Documentation Skills

Microsoft Office

Organizational Skills

Problem Solving

Education

High School Diploma (GED)

Tools

Calculator

Cleaning Equipment

Job description

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 Custodian to join our team in Boothwyn, Philadelphia.

You will lead in the daily execution of cleaning/sanitization procedures of the facility, equipment and instruments, complying and adhering to Good Manufacturing Practice (GMP) standards.

Main tasks and responsibilities

• Lead in the execution of activities to minimize the delay of production
  • Interpret schedule and make decisions to maximize the flow of cleaning activities
• Review or second check cleaning of equipment and associated documentation
• Liaise with Material Management and/or arrange order for manufacturing consumables
• Ensure enough GMP supplies are available in the Manufacturing Area
• Train personnel on GMP Area Cleaning and equipment cleaning
• Perform Facility Sanitization & Equipment Cleaning Procedures
• Perform Equipment Disassembly & Cleaning with minimal supervision
• Document cleaning activities in corresponding GMP documents
• Follow GMP procedures in cleaning and documentation

Additional Tasks/responsibilities

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

The Candidate

• The ideal candidate will have a HS diploma (GED) with some experience of GMP manufacturing or equipment maintenance/calibrations preferred.
• Competent in the use of Microsoft Office packages including Word, Excel and Windows Operating System.
• Experience and knowledge of cleaning within a GMP regulated environment/department preferred.
• 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.
• The ability to 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.
• Organizational skills.

Application Requirements
When applying for a position with Quotient Sciences, 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, your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences 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.

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.