AddressThe Lead QC Scientific Officer is an experienced QC Analyst who both undertakes analysis and assists the QC Section Head with the day-to-day coordination and supervision of the team. This is a hands-on role within the Quality Control Chemistry department providing support to the Section Head to ensure appropriate throughput of samples whilst maintaining the highest standards of quality to meet regulatory requirements.
Key Responsibilities:
- Coordinate day to day scheduling of analytical work to meet the needs of internal/external customers.
- Perform routine and non-routine analysis and complete QC release of batches.
- Acting as a liaison between analytical staff, supervisors, clients and other departments.
- Be the first point of contact for problem resolution of laboratory issues (e.g. analytical/instrumentation problems, OOS investigations, scheduling) highlighting any issues that cannot be resolved timely.
- Coordinate, complete and provide technical support for project work (e.g. method transfer, method development/validation, pharmacopoeia method verification, continuous improvement, compliance activities, HSE activities).
- Write and review technical documentation (e.g. laboratory notebooks, SOPs, scientific reports, validation documents).
- Conduct insightful scientific investigations into unexpected results and deviations with a focus on identifying root cause and corrective/preventative actions.
- Work in accordance with GMP & Data Integrity requirements and in alignment with quality documents e.g. SOP’s, Analytical Methods, Specifications, etc.
- Support and encourage a “Quality Culture” throughout the QC Lab.
- Coordinate, conduct and supervise training in analytical techniques and laboratory procedures. Identify training/development needs within the department and ensure training remains current against up-to-date procedures.
- Provide coaching, mentorship and guidance to the team.
- Participation in achievement of critical and important metric by timely completion of actions and objectives.
- Ensure Practical Process Improvement culture by identifying and supporting continuous improvement initiatives to eliminate or/and reduce waste and non-value adding activities within the laboratory.
- Interact with off-site and on-site clients in a professional manner to maintain productive and collaborative relationships.
- Role model the 4i values: - Integrity – Intensity – Innovation - Involvement.
- Deputise for QC Management team members in their absence and carry out any other tasks which may be required from time to time.
Eh&s:
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.
Qualifications/Experience:
- Degree in Chemistry/Biochemistry or strongly related scientific field.
- Minimum of 5 years chemical analytical laboratory experience.
- Minimum of 3 years GMP laboratory experience.
- Experience of broad range of instrumental and analytical techniques.
- A practical, proven understanding of Good Manufacturing Practice and Good QC Laboratory Practice.
- Experience of working to challenging and critical time lines whilst maintaining focus, accuracy, attention to detail and organisational skills.
- Experience of training/coach others.
- Excellent communication skills (both verbal and written) across all levels of management within the business.
- Be a self-starter with the ability to perform routine activities within minimal direction.
- Strong literacy, numeracy and computer literacy.
Our 130,000 global colleagues deliver an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD! For more information, please visit www.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer, and we do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
