QA Assistant
QA Assistant
Sittingbourne, Kent
BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets.
We currently have an opportunity for a QA assistant to join our team in Sittingbourne.
The Person
As the QA Assistant, you will have responsibility for the document management system, ensuring that documents are managed and stored appropriately in accordance with GMP and local regulations. As such, you will be process driven, with an organised and methodical approach. The ability to prioritise, manage time well, multitask and troubleshoot will be paramount to your success.
You will have strong interpersonal, communication and customer service skills. You will also need to have excellent IT skills and be well-versed in Microsoft Office products. The ability to create KPI reports and use pivot tables would be desirable.
The Role
The roles and responsibilities of the QA Assistant include, but are not limited to:
- Ensure that all documentation activities comply with ISO9001 and ISO13485 and GMP requirements as applicable to the site.
- Management of the site and Group document control systems
- Checking of documents to meet standard templates.
- Control of the of the site Approved Supplier List
- Control and issue of any official records including but not limited to production records, equipment monitoring records, quality records etc.
- Maintain & support the company’s archive systems
- Compilation of quality performance metrics
- Support the implementation of document changes ensuring that all the required signatures are in place prior to implementation
- Logging of customer complaints, CAPA and Deviations into the Document management system
- Become an expert in using and administration of the site eQMS (Qpulse)
- Investigation of non-conformances relating to routine activities.
- Supporting in regulatory and customer audits
- Presenting to internal auditors for relevant activities
The Package
The salary offering for this role is competitive and makes up part of BBI’s attractive benefits package, which includes:
- 5% contributory pension scheme.
- Life Assurance
- Private health care scheme.
- 28 days’ holidays (inclusive of bank holidays) with 4 additional days off:
- 1 day for your birthday
- 3 days when the business shuts down between Christmas and New Year.
- Participation in the childcare voucher and cycle to work schemes.
The Company
BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging.
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