Provide statistical support to Strip Manufacturing Umnit (SMU) to maintain production output and yields (within manufacturing and Product Test) at acceptable levels such as not to limit product availability, which could impact customer service.
Provide statistical support for design changes, validations, general specification setting and sampling plans.
Ensures that sound statistical methodologies are used and maintained in relation to areas such as product release testing, validation support and process monitoring and ensure that the requirements for statistical techniques are understood by other members of Technical SMU.
Provides statistical support, direction and sets an example to less experienced members of TSMU, e.g. Statisticians and Technologists.
Quality & Compliance
Ensures that all work is carried out in compliance with ADC processes and procedures.
In particular that any analysis, investigative and characterisation work is verified and documented appropriately.
On market changes are conducted through appropriate design controls.
Takes ownership for assigned tasks within ERs, CAPAs and VMP activities, ensuring timely progression.
Is aware of, and complies with, the Health and Safety requirements of ADC UK.
Works in a manner that ensures the safety of themselves, others and the environment.
Provide statistical support to New Product introduction (NPI) into SMU.
In particular provide support to the characterisation, validation and verification of new products and tests, as part of their transfer in to SMU.
May take ownership of multiple tasks / objectives associated with statistical support of the NPI. Ensures appropriate setup of monitoring new products when introduced.
Responsible for ensuring generation, analysis and interpretation of appropriate measures, i.e. in process and release test data, to allow the proactive identification of events that could cause substandard product and lot failures within PT.
To help generate and review data to identify potential areas of inefficiency to drive continuous process, and product, cost and quality improvements in SMU. Supports cost improvement projects.
A good understanding of data sources and the processes by which data is generated within SMU, i.e. manufacturing, IMA and Product
Test, allowing the appropriate data to be analysed to help to identify variables that may impact process efficiencies and capacities.
Responsible for identifying and delivering tasks required to achieve assigned objectives with minimal supervision, either as part of a bigger project or individual activities.
Responsible for the analysis of data and supporting the interpretation of results, to determine necessary trials to meet the objectives of projects and investigations within their remit.
Determine the tasks, resource and time required to execute tasks to meet objectives.
Ensuring that objectives are met in a timely manner to allow the overall projects or investigations to deliver.
Responsible for the development of experimental designs in order to achieve greater understanding of processes and drive improvements.
Liaise with appropriate resources to enable the completion of objectives.
Participate in and, if appropriate, lead crossfunctional teams to help achieve the objectives in a timely manner.
Communicate results of tasks either by verbal, written or visual methods.
Ensure the highest level of reporting is achieved by themselves and those supporting their objectives.
Ensure effective communication across TSMU, and beyond, on statistical activities.
Quality & Compliance
Responsible for ensuring statistical compliance of testing analysis for final release testing.
Ensuring that all justifications and conclusions from the interpretation of data are based on sound statistical rationale, if appropriate.
Development of approaches to data analysis to help projects to achieve the objectives of a set of tasks.
Ensure that investigations, ERs and CAPAs, including Product Test Failures, out of specification materials and Complaints, are supported through the statistical review of the appropriate data.
Responsible for reviews and updates calibration schemes for on market products.
Maintain appropriate records of activities and tasks carried out, in compliance with the ADC Quality System.
Ensure the generation and reporting of metrics on Product Test performance, occurs in a timely manner to remain compliant to ADC Quality system requirements.
Compliance with EHS regulations and Abbott standards by adhering to EHS systems, programmes and procedures.
Being accountable for the Health & Safety of themselves and others and by highlighting where improvements to EHS performance can be made.
Responsible for providing support for the characterisation and validation of new products. May be involved in the development of acceptance criteria and sampling plans for validation.
Support final release specification setting and responsible for setting test validity criteria where necessary.
Ensure manufacturing are supported and represented when new products are introduced, particularly with respect to the development of
calibration schemes and release specifications.
Through the analysis and statistical interpretation of appropriate data, e.g. process and Product Test, help to identify potential issues and areas for improvement within SMU.
Work with other members of TSMU to develop proposals and plans to help realise possible benefits of potential areas for improvement identified above.
As part of this help assess the benefit relative to the effort to realise these changes, in order to allow prioritisation to be made.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.
ACCOUNTABILITY / SCOPE/BUDGET:
Major contributor to the achievement of projects and investigations in order to meet key business goals.
Understands the impact of their actions on SMU and ADC UK goals.
Provides direction and support to peers and subordinates, as appropriate, to meet their objectives, in alignment with site priorities.
Responsible for ensuring the accuracy, quality, and timeliness of the documentation of any activities carried out to meet their objectives.
Responsible of ensuring the objectives are delivered to plan and that any deviations from plan are communicated appropriately in a timely manner.
Ensure that all work complies with the ADC Quality and EHS guidelines; may assume roles of responsibility, such as training or document control.
To perform other specific statistical tasks as required when directed.
Skills/Experience Requirements Must have a high level of numeracy skills, particularly when used in conjunction with computer software.
An ability to apply statistical techniques is required due to volume of data handled and the complexity of the tests surrounding it.
Experience in the use of SAS due to company wide usage of the package is required.
Experience of working in a regulatory occupation environment to understand the importance of compliance and quality.
Must have good communication skills both written and oral; to deliver technical information to a wide range of cross functional audiences.
Experience with databases and software systems to ensure the jobholder has sufficient knowledge to apply statistical techniques and analyse data.
Some experience of Test Method Validation, specification setting, sampling and/or design of experiments.
Education and experience should indicate the capacity to advance within the organisation.
Education Requirements HND in numerical science subject, with high statistics content, with significant progressive, relevant experience, or a degree with relevant experience.
Percent of Travel 0 - 20 %
Country United Kingdom
Site Location Witney, UK
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