Job Ref: 214972548

Date: 2021-10-21 16:58:39

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Scientific Quality Assurance Manager- FTC 6 months

Milton Keynes

The Job Role

The core services offered by our client include a wide variety of biological sample processing techniques which include COVID-19 swab testing, sample preparation and reformatting, nucleic acid extraction, quantification and normalisation, PCR, tissue preparation etc. UK They currently operate to ISO 9001:2015 and is in the process of applying for ISO 15189:2012 and ISO 17025:2015 accreditation.

The Scientific Quality Assurance Manager will act as consultative support function for a small team of staff within Quality whose purpose is to support a wide range of services and activities across the business. The Quality Department aims to support all departments in building and employing effective policies, procedures, controls and monitoring systems to ensure a high service level to clients and service users while maintaining and continually improving the quality management system.

Duties:

·Work with the operation team and Scientific Support and Development team to determine QSL work loads
·Act as the go-to person for quality issues in the company, with support from the Head of Quality, specifically those with a technical or scientific impact or remit.
·Support other quality team members in developing their professional skills and their understanding of the QMS specifically from a technical aspect.
·Chair regular quality meetings and provide status reports and updates to the Head of Quality.
·Provide data & support to the Head of Quality for QMS management review meetings.
·Develop, implement and control policies, procedures and documentation required by HTA, ISO 9001, ISO 15189, ISO 17025 certification and accreditation and any other accreditations that the UKBC go on to hold.
·All aspects of document control, including performing quality approvals for Standard Operating
Procedures, policies, manuals and risk assessments.
·Develop, maintain and deliver training presentations and materials relating to all aspects of the quality management system, including quality Inductions for all new staff.
·Assist in the development and maintenance audit calendars, including scheduling of audits.
·Perform internal audits to the requirements of ISO 9001:2015, ISO 15189:2012, ISO 17025 and HTA standards and UKBC documented processes.
·Report and investigate incidents and non-conformances.
·Monitor and follow up on the effectiveness of corrective actions applied within the QMS.
·Work with the procurement team to establish quality requirements of external suppliers’ products
and services.
·Must work in accordance with the requirements of ISO 9001, ISO 15189, iso 17025 HTA and UKBC defined procedural documentation relevant to the position and workplace.
·Promote a positive culture respect to the Quality systems developed
·Must carry out any other duties as deemed appropriate to the role.

Essential Criteria

ü  Educated to degree level, or equivalent employment experience in a relevant scientific field

ü  Previous laboratory experience

ü  Experience using Q-Pulse software

ü  Experience of ISO 15189 and/or 17025 would be a distinct advantage

ü  Experience of training/mentoring others

ü  Knowledge and experience of working to ISO 9001:2015 standard.

ü  Experience of identifying, investigating, analysing and resolving non-conformities.

ü  Excellent written communication skills, including formal report writing

ü  Strong verbal communication skills, including the confidence and ability to deliver training presentations clearly and methodically

ü  Good attention to detail

ü  Ability to multi-task and work flexibly

ü  Ability to positively influence others

Desirable Criteria:

Experience of internal auditing against ISO standards

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