Sr Administrative/QA Technician

Construction, Property and Engineering; Birmingham; On-site; GBP 18,000 - 21,000; Full time

Job summary

Randstad CPE is seeking a Sr QA Technician (Batch Release) in Birmingham to lead batch release activities, verify Device History Records, and ensure regulatory compliance. You will act as the quality documentation point of contact and support ongoing quality initiatives.

You will review DHRs, ensure ALCOA+ adherence, and collaborate with cross-functional teams. The role requires GMP/GxP knowledge and strong communication to drive quality across manufacturing processes.

Qualifications

• Minimum five GCSEs (Grade 5+) including English, Maths and Science.
• Experience in the Medical Device Industry.
• Sound knowledge of GxP standards (GMP, GDP, MDSAP, IVDR).
• Proficiency in Microsoft Office tools and familiarity with MasterControl.
• Strong communication, problem-solving, attention to detail, and workload prioritisation.
• Willingness to travel off-site within a 20-mile radius occasionally.

Responsibilities

• Batch Release & DHR Review: verify compliance with DMRs, manufacturing procedures, and ERP information; resolve NCRs and CAPAs before release.
• Quality & Compliance: maintain GxP/GMP/GDP/MDSAP/IVDR compliance.
• Process Improvement: participate in QA standardization and batch documentation revisions.
• Collaboration & Communication: work with cross-functional teams and support training.
• KPI & Metrics Tracking: collect and communicate KPIs and analyze quality trends.

Skills

MS Office

GxP knowledge

Problem-solving

Attention to detail

Communication

Project management

Education

GCSEs (5+) including English, Maths, Science

Tools

MasterControl

SharePoint

Teams

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.