Key Responsibilities

• Coordinate activities required to support manufacturing operations and ensure the successful delivery of clinical manufacturing (CMC and CTM) projects, along with IMP packaging and labelling activities.
• Prepare, review and approve manufacturing documentation, including Batch Manufacturing Records, packing instructions and associated GMP documentation.
• Ensure all work is documented accurately and completed in compliance with relevant regulatory requirements, internal procedures and client expectations.
• Manage and maintain GMP material inventories, including ordering, goods receipt, storage and stock control activities.
• Liaise effectively with Quality Control, Microbiology and Purchasing teams to ensure materials are available to support manufacturing schedules.
• Support the investigation, completion and approval of quality events, including deviations, change controls and other quality records.
• Promote and maintain high standards of health and safety, ensuring safe working practices are followed at all times.
• Work flexibly across the site to support business priorities and operational requirements.
• Provide support and deputise for the Head of Drug Product Operations when required.

Experience Required

• Experience working within a pharmaceutical, biotechnology or GMP-regulated manufacturing environment.
• Knowledge of GMP requirements and pharmaceutical manufacturing documentation.
• Experience preparing, reviewing and approving manufacturing records and controlled documentation.
• Strong organisational skills with the ability to manage multiple priorities and meet project timelines.
• Excellent attention to detail and a commitment to quality and compliance.
• Experience managing inventory, materials or supply chain activities within a regulated environment is advantageous.
• Strong communication and stakeholder management skills, with the ability to work effectively across multiple departments.
• A proactive and collaborative approach to problem-solving and continuous improvement.

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.