QC Associate

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Job ID :

51467BR

Location :

United Kingdom - Bishops Stortford

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:

A high degree of accuracy and attention to detail
Ability to read and interpret general procedures and governmental regulations
Good problem solving skills
Ability to effectively present information and respond to questions from groups of managers, clients and inspectors
Ability to calculate figures and amounts such as proportions, percentages, area, and volume
Proficient in personal computer skills; specifically Microsoft Office, Outlook and database management
Good verbal and written communications
Ability to demonstrate experience of working without direct supervision/under own initiative within the remit of the role
Builds good working relationship with others
Able to work under pressure and to support others within the team
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

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
May be required to perform off site work where necessary
Travel as required

Although not essential, the following skills and experience would be preferred: