Team Lead

About Us

**About the role**:
Team Lead - Laboratory Services is responsible for the daily technical operation of the microbiology laboratory, supervising a team of microbiology staff, overseeing the laboratory testing schedule and ensuring all microbiological testing, processes, methods, and validation exercises conform to internal procedures, reflect applicable regulations/guidelines and meet industry best practice.

**Your key duties and responsibilities**:

- Working within a controlled ISO13485 laboratory quality system and in accordance with GLP/GMP compliant procedures.
- Supervise a team of 3-6 microbiology staff.
- Ensures microbiology lab staff are trained and proficient at their assigned tasks and follow established standard procedures for the tasks they are performing.
- Conducts General Laboratory Compliance Awareness training as part of new starter inductions; ensures lab compliance with applicable cGMP regulations and SOP’s.
- Takes responsibility for the daily technical operation of the microbiology laboratory.
- Oversees the laboratory testing schedule and ensures all microbiological testing, processes, methods, and validation exercises conform to internal procedures, reflect applicable regulations/guidelines and meet industry best practice.
- Responsible for prioritisation of tasks to ensure deadlines are met in accordance with testing schedules.
- Represents the Microbiology Lab as a functional lead on various teams.
- Deputize in the absence of a laboratory manager; represents the microbiology laboratory during internal and external audits.
- To troubleshoot issues as they occur in the microbiology laboratory and manage deficiencies, OOS’s, non-conformances and failures with respect to equipment, procedure, processes and test methods within the laboratory.
- Ensure all laboratory instrumentation and equipment are appropriately calibrated in accordance with regulatory requirements and calibration schedules.
- Ensures microbiology equipment is fully qualified (IQ/OQ/PQ) to expected standards; supports software validation activities as and when required.
- Write COSHH and risk assessments for laboratory procedures.

**Skills & Experience**:

- 5+ years of Microbiology Laboratory work experience responsibilities.
- Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (preferable ISO13485:2016, ISO9001:2015, FDA 21 CFR part 820 or equivalent), GMP and GDP.
- Working knowledge and experience of microbiology related pharmacopeial/ISO standards.
- Experience of supervising staff in a laboratory setting.
- Background in microbiology; experience, track record and knowledge within microbiology or a laboratory environment.
- Demonstrated excellent analytical and problem-solving skills and ability to interpret data from a variety of sources.
- Excellent SOP, investigation, protocol, and technical report writing skills.
- Microsoft Office skills are essential.
- Ability to work effectively and communicate in cross-functional teams, building co-operative working relationships.
- Highly motivated, possessing excellent personal attributes as well as being a flexible team member willing to take on a wide variety of tasks.

**Qualifications/Education**:

- Degree qualified, ideally in Microbiology, Biology or a similar related discipline.
- Knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, FDA 21 CFR part 820) and GMP Guidelines and Regulations is desirable.
- Good working knowledge of Microsoft Office, specifically Word and Excel.

**Travel Requirements**:

- Position may involve mínimal travel, between 1-5 days per year.

**Working Conditions**:

- This role may be based in the Deeside with an onsite working structure.
- Laboratory/Office Environment
- Working in a laboratory environment with exposure to biological agents, chemicals and reagents.

**Special Factors**:

- Exposure to biological agents (Hazard Group 1 and 2).

**Ready to join us?**

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**Equal opportunities**

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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