Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific operates a facility at Unit 3, Fountain Drive, Inchinnan Business Park, Renfrewshire (PA4 9RF), UK. Associated with its UK entities Invitrogen Ltd and Life Technologies Ltd., the site supports laboratory and biotechnology operations under ISO standards, contributing to quality and manufacturing activities within Thermo Fisher’s global life sciences network.

Position Objective:

This role supports our Oligo Manufacturing processes, ensuring that the operations, processes, and procedures that affect product quality and/or integrity comply with in-house standards and ISO 13485.

Essential Functions:

• Perform final batch record review on all products and manage process of collating the BMRs from manufacturing

• Review and maintain SOPs, WINs and FRMs for QA team and update as required

• Prepare and review Certificates of Analysis upon customer request

• Perform QA and manufacturing record archiving and manage process of requesting records from storage when required

• QA review of logs and records within operations

• Use of Trackwise to record deviations and non-conformances as well as perform QA owner responsibilities for other records in Trackwise

• Provide QA support to manufacturing and other appropriate departments as required

• Attend, participate in and provide data for QA and Primers team meetings as appropriate

• Participate in PPI activity, including Quality Gemba walks and Kaizens and regularly utilize continuous improvement methodologies in daily work

• Participate in longer term projects to drive process improvement

• May attend RCCM activities as appropriate

• Participate in investigations into technical complaint cases

• May back up / support Seniors as required

• Cross train team members

• May be required to perform other related duties as required and/or assigned

Education:

Minimum of HND in Quality or Science preferable.

Experience:

QA/QC experience in a relevant environment. Knowledge of computer applications and current software (Word / Excel) is essential.

Contacts:

Will liaise extensively with all other departments on matters relating to quality and service in order to uphold the Company’s commitment to Customer satisfaction. This involves working with people at all levels within the organisation as well as external customers and regulatory bodies.

Working Conditions:

Works in an office/lab environment. Must be able to work overtime to complete daily tasks if required.