Product Quality Assurance Officer

summary
- _ dundee, scotland_
- _ £12.82 per hour_
- _ contract_- specialism
- graduate- sub specialism
- pharmaceuticals- reference number
- KM2844
- job details

Job Title: Product Quality Assurance Officer

Contract: 12 months

Location: Dundee

Shift Patterns: 6Am-2Pm & 2Pm-10Pm

Pay Rate: £12.82 Per hour plus £3250 shift premium per annum.

Job Overview:
This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out, working as part of the Product Quality Assurance Team, the Product Quality Assurance Officer is primarily responsible for the audit of manufacturing batch records, material inspection and approval.

Job 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.
- Working as part of a cross-functional team, attend and participate in Tier Review Meetings within a Management Operating System, to facilitate the flow of material through the factory on a daily basis.
- Working as part of a cross-functional team, perform document control activities; coordination of the document introduction, amendment and obsolescent process within an electronic document management system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval.
- 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 group.
- Proposing ideas for new opportunities to improve communication and productivity.
- Being aware of the policies as set out.
- Carries out other duties as and when requested by Line and or Department Manager.

**Required Skills**:

- 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)
- Experience with Electronic Document Management Systems (EDMS)
- Proficient with MS Word, Excel and Power-Point.
- A practical understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In
- vitro Diagnostics
- An ability to employ state-of-the-art Root Cause Analysis (RCA) tools, including A3/DMAIC.
- The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).

Randstad Business Support is acting as an Employment Business in relation to this vacancy.

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Job Title: Product Quality Assurance Officer

Contract: 12 months

Location: Dundee

Shift Patterns: 6Am-2Pm & 2Pm-10Pm

Pay Rate: £12.82 Per hour plus £3250 shift premium per annum.

Job Overview:
This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out, working as part of the Product Quality Assurance Team, the Product Quality Assurance Officer is primarily responsible for the audit of manufacturing batch records, material inspection and approval.

Job 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.
- Working as part of a cross-functional team, attend and participate in Tier Review Meetings within a Management Operating System, to facilitate the flow of material through the factory on a daily basis.
- Working as part of a cross-functional team, perform document control activities; coordination of the document introduction, amendment and obsolescent process within an electronic document management system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval.
- Taking