Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled 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 and Patheon. For more information, please visit www.thermofisher.com
Job Title: Quality Control Associate (Fixed Term)
Reports To: Quality Manager
Group/Division: PSG/CTD
Career Band: 3
Job Track: Associate
Position Location: Fisher Bioservices UK, Bishop’s Stortford
Number of Direct Reports: 0
Day/Shift (if applicable): 37.5 hrs per week/Core shift
This position is within the Bishop’s Stortford business unit of Thermo Fisher Scientific. Responsible for supporting the Quality Systems and ensuring activities performed are following UK/EU GMP and all other applicable local, regional or national regulations and standards. Accurately performs QC checks as trained. Perform documentation review to ensure compliance and support the Quality Manager where applicable
QC Associate is to gain competency in the following key responsibilities. Until the QC Associate has been documented as competent, these duties MUST be performed under the supervision of an On the Job Trainer.
Performing the following QC inspections:
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Receiving: to include, but not limited to, Review and approval where applicable of received goods and Rejecting incorrect goods and notifying appropriate personnel
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Packaging and Labelling: to include, but not limited to, following Production Order and perform Start, Middle and End Checks during production and provide assistance where required in the event of a production error
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Dispatch of Materials/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 notify appropriate personnel
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Kitting: to include, but not limited to, Start, Middle and End Checks during production and Provide assistance where required in the event of a kit production error
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Label Control: to include, but not limited to, Inspection of internally and externally printed labels against current specifications, Inspection of associated label documentation and Rejection and destruction of incorrect labels
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Updating inventory systems for QC release
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Identify, escalate and support investigations for any individual internal and/or external non-conformances, identified during QC checks, or notified to QC by another function
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Recording QC metrics as required
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Ensure all job-related paperwork is correct, error-free, and completed in real time as per SOPs
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Performing documentation review ensuring documentation is error free, GMP compliant and to ALCOA+ standards
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Perform adhoc duties, as requested by the Senior Quality Control Associate or Quality Manager, to support activities of the Quality department
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Support the business metrics in ensuring that all Company & Regulatory requirements for Environmental, Health & Safety (EHS) compliance through supporting EHS at the Bishop's Stortford site
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Support the culture of Continuous improvement through the PPI Lean process
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Exhibits appropriate behaviour, language and appearance at all times on the job or at company events
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A high degree of accuracy and attention to detail
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Ability to read and interpret general procedures and governmental regulations
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Good problem-solving skills
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Ability to effectively present information and respond to questions from groups of managers, clients and inspectors
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Proficient in personal computer skills; specifically, Microsoft Office, Outlook and database management
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Good verbal and written communications
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Ability to demonstrate experience of working without direct supervision/under own initiative within the remit of the role
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Builds good working relationship with others
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Able to work under pressure and to support others within the team
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This position functions in a repository environment, which may include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, as well as marked changes in temperature
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May be required to perform off site work where necessary
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Educated to A level or equivalent
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Experience working in a GMP (GxP) environment (desirable)
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Hands-on experience working with biological and/or pharmaceutical samples (desirable)
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Hands-on experience working in clinical packaging (desirable)
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Frequently required to type, sit, stand, walk, lift/carry up to 25kg. Occasionally required to push/roll 280kg lb liquid nitrogen dewars and 4-S00kg freezers, and work from a platform ladder
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Employment is subject to 10 year screening for criminal records, qualifications, previous employment and credit history- Thermo Fisher Scientific have the right not to employ people failing to meet the standards required
