Job Description
We are seeking an enthusiastic analyst to support analytical method validation, method transfers in Biology and Microbiology labs, and qualification of critical reagents for bio-assays.
Key Responsibilities:
* Expertise in Immunology techniques (e.g., ELISA, hemagglutination)
* Conduct method validation, improvements, and test transfers
* Produce and validate biomaterials for testing
* Support change management for new methods and equipment validations
* Create technical documentation (protocols, plans, reports)
* Update SOPs and GMP documents
* Prioritise and manage multiple projects
* Communicate results and collaborate with various departments
* Investigate lab deviations, report OOS/OOT results, and implement CAPA actions
Other Responsibilities:
* Adhere to GMP, ESH procedures, and our company policies
* Maintain documentation and training records per GMP
* Ensure effective communication with team members and stakeholders
Person Specification:
* Knowledge: Strong understanding of GMP Quality Systems and technical expertise in immunology and microbiology
* Experience: Significant experience in laboratory testing, investigations, and method validation; interaction with operations and technical teams
* Skills: Proficient in Microsoft Office, good writing skills, troubleshooting ability, and basic statistical knowledge (e.g., Minitab)
* Attributes: Self-motivated, organized, flexible, clear communicator, detail-oriented
* Qualifications: Degree in Biology/Microbiology (PhD preferred)
Other Requirements:
* Cross-functional work experience and proven problem-solving skills
* Full UK driving licence
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