Qc Associate

3 months ago


Bishop's Stortford, United Kingdom Thermo Fisher Scientific Full time

**Job Title: Quality Control Associate**

**Location: Bishops Stortford**

**Position Summary**:
This position is responsible for supporting the Quality Systems and ensuring activities performed are following EU GMP / ISO 9001 / HTA / MHRA / and other applicable regulations and standards. Accurately performs QC checks as trained. Perform documentation review to ensure compliance and support the QC Supervisor where applicable.

**Key Responsibilities**:
With training and working in a team the QC Associate will gain proficiency in the following key responsibilities.

Perform the following QC inspections, including but not limited to:

- Receiving - Review and approval of received goods, rejecting incorrect goods and notifying appropriate personnel.
- Packaging and Labelling - Follow Production Order instructions and conduct QC process checks during production and provide support following production errors.
- Dispatch of Materials/Equipment/Kits - Perform final inspection of packed orders prior to collection, release orders for collection, rejecting incorrect orders and notify appropriate personnel.
- Kitting - Perform in process inspections during kitting and provide assistance where required in the event of a kit production error.
- Label Control - Inspection of internally and externally printed labels against current specifications, Inspection of associated label logbooks and Rejection and destruction of incorrect labels.
- Updating inventory systems for QC release.
- Identify, raise and support investigations for any individual internal and/or external non-conformances, identified during QC checks, or notified to QC by another function.
- Recording QC metrics as required.
- Ensure all job-related paperwork is accurate, error-free, and completed in real time as per SOPs.
- Performing documentation review ensuring documentation is accurate, complies to GMP and ALCOA+ standards.
- Perform adhoc duties, as requested by the Quality Team Leader or Quality Manager, to support activities of the Quality department.
- Support the business metrics in ensuring that all Company & Regulatory requirements for Environmental, Health & Safety (EHS) compliance through supporting the EHS Manager.

**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.
- Proficient in personal digital literacy; 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 collaborations.
- Able to work under pressure and problem solve in order to support others within the team.
- 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.

**Minimum Requirements/Qualifications**:

- Preferably educated to Degree level.
- Experience working in a GMP (GxP) environment (desirable).
- Experience working with biological and/or pharmaceutical samples (desirable).
- Practical experience working in clinical packaging or equivalent (desirable).
- Frequently required to type, sit, stand, walk, lift/carry up to 25kg. Occasionally required to push/roll 280kg lb liquid nitrogen dewars and 4-500kg freezers, and work from a platform ladder.

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Thermo Fisher Scientific is an Equal Opportunities Employer and does not discriminate on the basis of race, colour, religion, sexual orientation, gender identity, national origin, disability or any other legally protected status.