Full job descriptionAre you a detail-oriented professional looking to contribute to high-quality manufacturing standards? Do you possess a keen eye for compliance and a background in regulated environments? If you are committed to operational excellence and thrive in a collaborative environment, this role may be the perfect fit for your career progression.


Job Details:
Titile: Product Quality Assurance Officer
Pay rate: £16.41 per hour with £1.79 per hour shift premium
Contract: 12 months (potentially extended)
shift hours: onsite 5 days a week, 2 weeks on 2 weeks off, 6am-2pm & 2pm-10pm
Location: Dundee
Responsibilities:
*Compliance Audit of Manufacturing Records; Rare Reagent, Buffers, Bulk Formulation, Dispensing and Kit Pack.
*Compliance audit of QC test records.
*Material inspection versus specification; sub-assemblies, intermediates and finished kits.
*Material control within ERP System; approval, reject, rework, quarantine.
*Approve Quarantine removal and rework operations.
*Performing Archiving activities for Device History Records per record retention policy to maintain both on-site and off-site records archive.
*Support the Management Operating system by attending and participating in the Tier Review Meetings process to track team progress on a daily basis
*Taking full accountability for personal workload, ensuring work is completed to a high standard in accordance with site policies, procedures and applicable regulations.
*Proactively contributing to continuous improvement initiatives and other general housekeeping duties.
*Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
*Developing excellent relations with the Department team and wider Operations and Quality groups.
*Proposing ideas for new opportunities to improve communication and productivity.
*Being aware of the policies as set out in the Client’s Employee Handbook
*Carries out other duties as and when requested by Line and or Department Manager
Background:
*Good attention to detail
*Excellent timekeeping and organisation skills
*Good communication skills, written and spoken
*Able to work flexibly and as part of a small team
*Experience with an Enterprise Resource Planning System (ERP) preferred
*Experience with Electronic Document Management Systems (EDMS) - preferred
*Proficient with MS Word, Excel and Power-Point.
*Awareness and understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In-vitro Diagnostics preferred, training will be provided.
Base Requirement:
*SQA Qualification at Nat 5 level or equivalent in Maths, English and a science subject and/or
*Relevant experience within a regulated industry
Randstad Business Support is acting as an Employment Business in relation to this vacancy.