QC/QA Officer

Hyper Recruitment Solutions LTD; Newcastle upon Tyne; On-site; GBP 38,000 - 55,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a QA/QC Officer to join a leading specialist pharmaceutical organisation in the North East. You will support QC testing, release of radiopharmaceuticals and maintenance of the Radiopharmacy in line with GMP and EP requirements.

You will contribute to quality systems, environmental monitoring and validation activities, training Technicians and collaborating with production and quality teams to ensure patient-focused outcomes.

Qualifications

• Degree in a relevant scientific field (e.g., Pharmaceutical Chemistry, Chemistry, Biology, Radiopharmacy).
• Proven experience in quality control with GMP and interpretation of analytical/microbiological data.
• Radiopharmacy experience is desirable; may require shift work.
• Excellent attention to detail, communication and organizational skills, teamwork and time management.

Responsibilities

• Support the quality control and release of manufactured radiopharmaceutical products in line with EP and GMP requirements.
• Review and maintain SOPs, forms, QC logbooks, quality records and trackers to support compliance and data integrity.
• Assist with quality management system activities, including deviations, incidents, CAPA, change control, complaints, recalls, risk assessments and root cause analysis.
• Perform and coordinate environmental and radiation monitoring, microbiological testing, facility/isolation cleaning, incoming goods inspections and equipment checks.
• Assist with training Technicians in QC activities and ensure compliance with safety and regulatory procedures.

Skills

Quality control experience

GMP knowledge

Data integrity

QMS

Environmental monitoring

Radiopharmacy knowledge

Attention to detail

Teamwork

Education

Bachelor's degree in a relevant scientific field

Job description

We are currently looking for a QA/QC Officer to join a leading specialist pharmaceutical organisation based in the North East. This is an exciting opportunity to support the quality control of radiopharmaceutical products and the maintenance of a Radiopharmacy in accordance with Good Manufacturing Practice (GMP).

The successful candidate will contribute to quality systems, environmental monitoring, validation activities and accurate QC testing, while working collaboratively with production and quality teams to support patient-focused outcomes.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the QA/QC Officer will be varied however the key duties and responsibilities are as follows:

• Support the quality control and release of manufactured radiopharmaceutical products, ensuring testing is completed accurately in line with applicable product specifications, European Pharmacopoeia (EP) requirements and GMP guidelines.
• Review and maintain SOPs, forms, QC logbooks, quality records and trackers to support compliance, data integrity and ongoing site objectives.
• Assist with quality management system activities, including deviations, incidents, Out of Specification results, CAPA, change control, complaints, recalls, risk assessments, investigations and root cause analysis.
• Perform and coordinate environmental and radiation monitoring, microbiological testing, facility and isolator cleaning, incoming goods inspections, equipment checks and relevant validation activities.
• As the QA/QC Officer you will support effective communication across production and quality teams, train Technicians in QC activities, assist with equipment maintenance and help ensure all legal, safety, health, environmental and organisational procedures are followed.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the QA/QC Officer we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant scientific field, such as Pharmaceutical Chemistry, Chemistry, Biology, Radiopharmacy or a related discipline.
• Proven experience in quality control, with knowledge of pharmaceutical chemistry, GMP and the accurate review and interpretation of analytical or microbiological data.
• Radiopharmacy experience and knowledge of radiation are desirable, alongside the flexibility to undertake shift work where required.
• Excellent attention to detail, communication and organisational skills, with practical ability, basic computer proficiency, strong teamwork, effective time management and the ability to manage competing priorities.

WHAT'S IN IT FOR YOU?

• The opportunity to contribute to the quality and safety of radiopharmaceutical products that support patient care.
• A varied role combining quality control, quality systems, environmental monitoring, validation and Radiopharmacy activities.
• The opportunity to develop leadership capability by supporting Technician training and contributing to GMP compliance across the site.
• The chance to work collaboratively with production and quality colleagues in a supportive, detail-focused environment.

Key Words: QA/QC Officer / Quality Control / Radiopharmacy / Radiopharmaceuticals / Good Manufacturing Practice / GMP / Quality Management System / QMS / Environmental Monitoring / Microbiology / Validation / CAPA / Deviations / Out of Specification / OOS / Data Integrity / Pharmaceutical Chemistry / Quality Assurance / Nuclear Medicine

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.