Job ID :
51467BR
Location :
United Kingdom - Bishops Stortford
:
Job Description
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $17 billion, we have approximately 50,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
Job Title: Quality Control Associate I
Reports To: QC Team Manager
Group/Division: Thermo Fisher Scientific/BioPharma Services Division
Career Band: 3
Job Track: Associate
Position Location: Fisher BioServices UK - Bishops Stortford
Number of Direct Reports 0
Day/Shift (if applicable): 37.5 Hours per Week / Core shift
Position Summary:
Responsible for supporting the Quality Systems and ensuring activities performed are following EU GMP/ ISO 9001/ HTA/ MHRA/ HFEA and other applicable regulations and standards. Accurately perform QC checks in Receiving, Dispatch, Packaging, Labeling and Kitting. Perform documentation review to ensure compliance and support the Senior Quality Control Associate where applicable.
Key Responsibilities:
Operator is to gain competency in the following key responsibilities. Until the operator has been documented as competent, these duties MUST be performed under the supervision of an expert.
Minimum Requirements/Qualifications:
Company Information
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $17 billion, we have approximately 50,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
Job Description
Job Title: Quality Control Associate I
Reports To: QC Team Manager
Group/Division: Thermo Fisher Scientific/BioPharma Services Division
Career Band: 3
Job Track: Associate
Position Location: Fisher BioServices UK - Bishops Stortford
Number of Direct Reports 0
Day/Shift (if applicable): 37.5 Hours per Week / Core shift
Position Summary:
Responsible for supporting the Quality Systems and ensuring activities performed are following EU GMP/ ISO 9001/ HTA/ MHRA/ HFEA and other applicable regulations and standards. Accurately perform QC checks in Receiving, Dispatch, Packaging, Labeling and Kitting. Perform documentation review to ensure compliance and support the Senior Quality Control Associate where applicable.
Key Responsibilities:
Operator is to gain competency in the following key responsibilities. Until the operator has been documented as competent, these duties MUST be performed under the supervision of an expert.
- Performing the following QC Checks:
- Receiving – to include but not limited to; Review and approval where applicable of received goods and Rejecting incorrect goods and notifying appropriate personnel
- Packaging and Labeling – to include, but not limited to; Line Clearance checks, Start up, middle and End Checks during production and Provide assistance where required in the event of a production error
- Dispatch of Material/Equipment/Kits – to include, but not limited to; Final inspection of packed orders prior to collection, Release of packed orders for collection and Rejecting incorrect orders and notifying appropriate personnel
- Kitting – to include, but not limited to; Line Clearance checks, Start up, middle and End Checks during production and Provide assistance where required in the event of a kit production error
- Label Control – to include, but not limited to; Inspection of internally and externally printed labels against label specifications, Inspection of associated label log books and Rejection and destruction of incorrect labels
- Laboratory Processing; Performing inspections as required
- Updating inventory systems for QC release.
- Identify, escalate and support investigations for any identified internal and/or external non-conformances, identified during QC checks, or notified to QC by another function.
- Recording QC Metrics as required.
- Performing documentation review of general processing documents such as, but not limited to; Receipt Records, Dispatch Records, Calibration Records, Line Clearance Records, Kit Production Records and Laboratory Processing Records
- To ensure during review documentation is correct, GMP compliant, error-free, and entered into operating systems appropriately.
- Perform adhoc duties, as requested by the Quality Team Leader or Quality Manager, to support activities of the Quality department.
Minimum Requirements/Qualifications:
- Educated to A-Level or equivalent, in relevant subjects.
Essential Skills / Experience:
Although not essential, the following skills and experience would be preferred:
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