Quality Control compliance Officer

Oxford Biomedica; Oxford; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in viral vector CDMO is seeking a QC Compliance Officer to ensure timely reporting of analytical data and manage quality records. This role involves continuous improvement to QC processes in compliance with GxP standards. Candidates should have a biological science background and experience in a regulated environment.

Benefits

Highly competitive total reward packages

Wellbeing programmes

Development opportunities

Welcoming, friendly, supportive colleagues

Diverse and inclusive working environment

Qualifications

• A Science graduate with a biological background or equivalent experience in a GxP environment.
• Knowledge of QC testing in a GMP setting.
• Experience with Quality Management Systems including raising quality records.

Responsibilities

• Ensure documentation adheres to GMP and GDocP principles.
• Perform data integrity checks on QC data.
• Manage projects with external contract testing organisations.

Skills

Attention to detail

Time management

Communication

Proactive mindset

Education

Science degree

Tools

LIMS

MS Office

Job description

We use science to save lives, and so can you.

We are currently recruiting for a QC Compliance Officer to join the Compliance teamin the Quality Control (QC) department. The purpose of this role is to ensure timely reporting of analytical data, to effectively manage quality records and quality control document updates, to implement continuous improvement to QC processes in line with GxP requirements and to manage external testing. This role is office based.

Our Quality Control department supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.

Your responsibilities in this role would be:

• Ensure documentation within the department is generated and used according to GMP and GDocP principles throughout the documentation lifecycle
• Perform data integrity checks on QC data prior to authorisation
• Carry out desk-based calculation assays and QC check equipment maintenance forms, non-technical internal assays and external testing reports
• Create and maintain QC databases, Certificate of Analysis (COA) and Certificate of Testing (COT)
• Draft external testing shipment paperwork packs including submission forms, dispatch notes and permit management
• Manage projects with external contract testing organisations, including attending calls, taking meeting minutes and actions, updating trackers and raising purchase requisitions
• Manage generation and updates to quality control testing documents and sampling plans
• Track key performance activities within the team and generate metrics for presentation to senior management

We are looking for:

• A Science graduate with a biological background or equivalent experience in a regulated pharmaceutical or GxP environment
• Knowledge of QC testing in a GMP setting and experience with Quality Management Systems including raising quality records
• Understanding of LIMS and how this can be used within a GMP environment
• Computer literate (outlook, word, excel, MS Office)
• Strong attention to detail and the ability to manage multiple tasks independently
• Excellent communication skills, a proactive mindset, and strong time management abilities
• An individual who is motivated, resilient and accountable for work and projects assigned

About Us:

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

What's in it for you:

• Highly competitive total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Responsible, Responsive, Resilient, Respect
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives

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