Manufacturing Coordinator

3 weeks ago


South Mimms, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

**Details**:
**Reference number**:

- 272398**Salary**:

- £27,837**Job grade**:

- Executive Officer**Contract type**:

- Permanent
- Fixed Term**Length of employment**:

- 12**Business area**:

- Science, Research, and Innovation**Type of role**:

- Other**Working pattern**:

- Full-time**Number of jobs available**:

- 2Contents

Location

About the job

**Benefits**:
Things you need to know

Location
- South Mimms, Hertfordshire/HybridAbout the job

**Job summary**:
We are currently looking for two **Manufacturing Coordinator** to join our (adjective) **Standards Lifecycle **Team within the **Science, Research, and Innovation** Group.

These are two **full-time **opportunities, one on a **permanent basis and one on a 12-month fixed term contract/internal move or temporary promotion **basis. The role will be based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

**Who are we?**

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Scientific Research and Innovation Group (SR&I) delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

The Markey Analysis, Manufacturing, and Logistics function (MML) is responsible for the processing, freeze drying, storage and distribution of biological standards. The Manufacturing Department fills, freeze dries, labels these standards working closely with the other MML functions to ensure global supply needs are met.

**Job description**:
**What’s the role?**

The post holder will organise and provide a range of services including the preparation, filling, freeze drying, sealing, quality control testing and labelling of biological reference materials including WHO reference materials, pandemic materials and influenza products associated with timely responses to global public health requirements, in accordance with quality standards

**Key responsibilities**:

- Accurately process biological materials using several different manufacturing lines, including the preparation and sterilisation of equipment and components, operation of complex filling machinery and freeze dryers, labelling and packing of products ensuring correct information for biological and chemical hazards is included to meet legislative demands, and storage at correct conditions.
- Carry out sampling and quality control testing on all biological materials processed including complex analytical methods for determining the residual moisture content and oxygen concentration in the headspace of the container.
- Accurately prepare and complete detailed relevant documentation to meet quality system demands such as manufacturing records, records of deviations and / or anomalies, corrective / preventative actions, quality control testing results, freeze drying documentation, decontamination certificates, correspondence from scientific staff to support manufacturing methods used.
- Maintain the cleanliness of the manufacturing environment according to recognised clean room standards with regular cleaning of walls, floors and manufacturing machinery including using a rotation of disinfectants and fumigation procedures after infectious procedures.

**Person specification**:
**Who are we looking for?**
- Working within a quality management system such as GMP, GLP or ISO 9001
- Team working experience
- Good communication skills.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification

**_

**Benefits**:

- Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
- Privilege Leave: 1 day
- Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
- Occupational Sick Pay (OSP): One month f



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