Sr Administrative/QA Technician

Career Choices Dewis Gyrfa Ltd; Birmingham; On-site; GBP 29,000 - 30,000; Full time

Job summary

Randstad CPE is seeking a Sr QA Technician (Batch Release) for an onsite role in Birmingham. The candidate will review DHRs, ensure batch release compliance, and maintain high quality standards across QA processes.

Responsibilities include ALCOA+ compliant DHR reviews, addressing NCRs and CAPAs, and supporting continuous improvement. Requires GMP/GDP/MDSAP/IVDR knowledge and proficiency with MS Office and MasterControl.

Qualifications

• GCSEs including English, Maths and Science.
• Experience in the Medical Device Industry.
• Knowledge of GxP standards (GMP, GDP, MDSAP, IVDR).
• Proficiency with MS Office and MasterControl quality system.

Responsibilities

• Batch Release & DHR Review following ALCOA+ to verify compliance.
• Ensure Quality Events, NCRs, and CAPAs are resolved before release.
• Maintain regulatory compliance with GxP/GMP/GDP/MDSAP/IVDR.
• Participate in QA improvement projects and batch documentation revisions.
• Collaborate with cross-functional teams and report KPI data.

Skills

GxP knowledge

MS Office

MasterControl

Attention to detail

Communication

Project management

Education

GCSEs (English, Maths, Science)

Tools

Microsoft Office

MasterControl

Job description

We are seeking a Sr QA Technician (Batch Release) to join our team in Birmingham . In this role, you will be responsible for performing batch release activities, ensuring regulatory compliance, verifying Device History Records (DHRs), and maintaining high quality standards . You will serve as a key point of contact for GXP documentation and support ongoing quality management initiatives . Key Responsibilities Batch Release & DHR Review: Review Device History Records (DHRs) following ALCOA+ principles to verify compliance with Device Master Records (DMRs), manufacturing procedures, and ERP information . Ensure Quality Events, Non-Conformance Reports (NCRs), and CAPAs are resolved prior to product batch release . Quality & Compliance: Maintain procedural and regulatory compliance (GxP, GMP, GDP, MDSAP, IVDR) . Process Improvement: Participate in continuous improvement projects, QA standardization activities, and batch review/release documentation revisions . Collaboration & Communication: Work closely with cross-functional teams, participate in training initiatives, and present quality-related information . KPI & Metrics Tracking: Collate and communicate key performance indicators (KPIs) to monitor operational quality and analyze trends . Role Details Location: Birmingham (Onsite) Employment Type: Full-time (40 hours/week) Contract Duration: 6 months Shift Pattern: Monday

• Friday, 08:30 - 17:00 Pay Rate: £13.94 per hour Requirements & Qualifications Education: Minimum 5 GCSEs (Grade 5 or above, or equivalent), including English, Maths, and Science . Experience: Previous experience in the Medical Device Industry . Regulatory Knowledge: Sound knowledge of GxP standards, specifically GMP, GDP, MDSAP, and IVDR . Technical Skills: Proficiency in Microsoft Office (Forms, Teams, SharePoint) and familiarity with quality management systems like MasterControl . Soft Skills: Excellent oral/written communication, problem-solving skills, strong attention to detail, project management capability, and the ability to prioritize workload . Other: Ability to complete a standard background check and travel off-site within a 20-mile radius on rare occasions . Randstad CPE values diversity and promotes equality.

No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

Jobs are provided by the Find a Job Service from the Department for Work and Pensions (DWP).