Are 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.
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