Biologist - Quality Control

4 weeks ago

Milton Keynes, United Kingdom Room At The Top Recruitment Full time

**Biologist - Quality Control**

Our global pharmaceutical client based in Milton Keynes is recruiting a Biologist to join their busy Quality Control team reporting to the Lead Technician, Quality Control Improvement Team. This is a contract role initially signed off for 9 Months with apossible extension offering an hourly rate of up to £20.50 per hour, plus 25 days holiday pro rata and other benefits. Hours are Mon
- Friday 37.5 hours per week.

**Company / Division Overview**

Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company - one that is ready to help create a healthier future for allof us.

Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, they strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team,you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

**Purpose of Role**:
Currently QC is looking for an enthusiastic and dedicated analyst to -- To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.
- Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc.

**Key Accountabilities & Duties**:

- Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
- Understanding of microbiology techniques such as sterility test is beneficial.
- Validation of biomaterials used in in-process and final product testing.
- Biology/Microbiology method validation / improvements and test transfer between labs/sites.
- Drive change management for introduction of new / improved methods and validation of new equipment.
- Be able to produce technical documents such as protocols, testing and execution plans and final reports.
- Ability to work on several projects simultaneously and be able to prioritise.
- Reporting and communication of results to stakeholders. Liaise with several departments - technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
- Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
- Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.
- Perform project related literature searches
- Interact closely with fellow scientists and global/regional colleagues within own and other departments.
- Work in a multi-disciplinary and international team and environment.

**Other responsibilities**
- Comply with Standard Operational Procedures (SOP’s), GMP, ESH procedures and Company corporate policies and process improvements.
- Maintain all documentation and training records as per GMP requirements.
- To comply with company’s health and safety practices and procedures.
- Ensure positive, timely and effective communication with team members and internal customers.

**Person Specification**

**Knowledge**:

- Good understanding and working knowledge of GMP Quality Systems
- Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.

**Experience**:

- Minimum 3 years of experience with excellent understanding of testing within a laboratory environment
- Laboratory investigations
- Validation and method development

**Skills & Abilities**:

- Proficient in use of Microsoft Office especially Excel and Word.
- Good Protocol and Report writing skills.
- Ability to troubleshoot to resolve issues
- Basic Statistical understanding Knowledge such as Minitab Statistical software (desirable)

**Personal Attributes**:

- Able to communicate at all levels and across all functions
- Ability to communicate concise technical information with clarity
- Able to assist in Fact finding discussions
- Flexible approach to changing priorities
- Attention to detail

**Qualifications**:

- Degree in Biology/Microbiology

**Other Requirements**:

- Cross functional work experience
- Demonstrated scientific problem-solving capabilities
- Full driving licence

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