Are you passionate about quality, compliance, and maintaining the integrity of critical GMP documentation in a fast-paced biotechnology environment?
R&D Partners is seeking a Quality Sr Specialist to join a leading biotechnology company in Runcorn, UK. This fully onsite role offers an exciting opportunity to contribute to quality operations and ensure compliance with GMP standards. The position is a 6-month contract, working Monday to Friday, 9:00 AM - 5:00 PM.
Please note that to be considered for this role you must have the right to work in this location.
Purpose of the Role:
The Quality Sr Specialist will support the control, storage, and retrieval of quality documentation while maintaining accurate, accessible, and confidential paper and electronic records. The role also involves providing general administrative support to the Quality team as required.
Responsibilities:
- Maintain controlled, accessible, and traceable quality documentation and archived records.
- Verify document identification, version, and approval status; issue controlled copies and withdraw superseded versions.
- Index, file, and archive paper and electronic records; log locations, retrievals, and returns.
- Apply approved retention and access rules while protecting record integrity; escal... missing/damaged records.
- Provide general administrative support to the Quality team as needed.
Key Skills and Requirements:
- Basic GMP knowledge and good documentation practices.
- Working knowledge of document-control and archive SOPs.
- Experience in a Quality role within the pharmaceutical or regulated industry (desirable).
- Accuracy and attention to detail when checking, handling, and recording information.
- Ability to organise workload, maintain confidentiality, and communicate clearly.
- Competence in using systems within training and authority, resolving routine problems, and escalating issues when necessary.
- Completion of document-control and archive training, with demonstrated competence in routine tasks.
Competencies:
- Collaboration: Ability to work effectively with peers and partners to positively impact performance.
- Planning & Organising: Structured approach to establishing plans, priorities, and goals.
- Drive & Resilience: Persistence to meet objectives and recover quickly from setbacks.
- Effective Communication: Clear communication tailored to the audience.
- Change & Adaptability: Ability to act upon change to achieve goals.
- Analytical Thinking & Problem Solving: Identifies causes of problems and provides practical solutions.
- Customer Focus: Understands and meets customer needs to ensure satisfaction.
- Integrity: Maintains high standards of honesty and trustworthiness.
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Quality Sr Specialist in Runcorn employer: R&D Partners
R&D Partners is an exceptional employer, offering a dynamic remote work environment that fosters collaboration and innovation in the pharmaceutical and biotech sectors. With a strong emphasis on employee growth, we provide ample opportunities for professional development and career advancement, all while supporting a culture of teamwork and excellence. Join us to be part of a forward-thinking organisation that values your contributions and prioritises your well-being.
