Senior Qc Specialist

2 weeks ago

Horsham, United Kingdom Thermo Fisher Scientific Full time

Business Job Title: Senior Quality Control Specialist Internal Job Title: Lead QC Technician

Reports To: Quality Control Lead

Group/Division: CTD

Career Band: 4

Job Track: Associate

Position Location: Horsham

Number of Direct Reports: 0

Day/Shift (if applicable): Late Shift

**Position Summary**: Under direction of the Quality Control Lead - Packaging / Despatch / Inventory, proactively support the execution of tasks by, and development of, the team of Quality Control Specialists.

Ensure the timely and accurate performance of QC checks in Inventory, Packaging and Despatch, providing the required levels of support and service to both the Quality Control Specialists and Operational functions.

To enable assurance of product compliance to item specifications and / or order requirements.

**Responsibilities**:

- QC Despatch - to include, but not limited to;
- First Inspections of materials picked for shipment where applicable
- Final Inspection of all orders prior to Despatch
- Shipment of all orders from the GPMS system
- Issue investigation and resolution
- QC Packaging - to include, but not limited to;
- Start up, Shift Check, End Check within Operation Production
- Quality Audits
- Line Clearances
- Issue investigation and resolution
- ** Key Responsibilities: (continued)**:

- Oversee the workloads of QC Specialists within QC Inventory, QC Packaging and / or QC Despatch, ensuring a ‘flow-to-work’ approach is permitted via utilisation of cross-trained personnel, escalating concerns to the attention of the appropriate Quality Control Lead.
- Interact with Operational Team Leaders/Managers to ensure that the QC team is appropriately allocated to meet operational demands
- Support the QC Specialists in the performance of QC checks and ensure GMP compliance within operational activities.
- Represent the first point for ‘Quality’ escalation in response to any issues / events identified during Operational activities, and seek to risk assess and to develop solutions as appropriate.
- Act as initial point of contact for client comments / queries in relation to QC processes and / or executed activities.
- Assist the Quality Control Lead(s) in the training / coaching / development of all QC Specialists to ensure individuals are competent and confident to perform required tasks consistently.
- Maintain compliance with GMP, HSE and ongoing Quality programmes
- Identify and develop continuous improvement initiatives, and proactively support their implementation at the discretion of the Quality Control Lead(s), working with individuals from across the business as necessary.
- Prepare new and /or review and enhance existing Standard Operating Procedures related to the processes for Quality Control, and functions supported by the QC team.
- Generate and update documentation required by QC / Operations to ensure it is fit for purpose, and collate metrics to demonstrate the performance of QC processes
- Support the investigations of any identified internal and/or external non-conformances identified during QC processes, or notified to QC by another function. At the discretion of the Quality Control Lead(s).
- Support the development, testing and / or delivery of corrective / preventative actions at the discretion of the Quality Control Lead(s).
- Assist with client audits as ‘Subject Matter Expert’ with reference to specific Quality Control processes.
- Deputise in the absence of the Quality Control Lead(s) as appropriate
- Perform adhoc duties, as requested by the Operational Quality Manager(s) or the Quality Control Lead(s), to support the activities of the Quality department, as required.

**Minimum Qualifications**:

- Preferably has 2-3 years+ related experience in pharmaceutical GMP and appropriate experience of working across various quality / packaging / distribution roles.
- Preferably has demonstrable leadership skills and capabilities.
- Able to demonstrate experience of working within a team, and of the provision of support, coaching and mentoring of others.
- Able to demonstrate experience of working without direct supervision / under own initiative within the remit of the role, and to lead teams / delegate tasks appropriately.
- Able to demonstrate considered use of discretion and own initiative.
- Responsibility / accountability for quality of own work, and of those under their direction.
- A high degree of accuracy and attention to detail.
- Competent in use of electronic / computerized systems.
- Good verbal and written communication.
- Good organizational skills.
- Proven problem solving and decision making skills.

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