Overview:
We are a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs.
You’ll be part of a cross functional team of 10-12 highly motivated and collaborative colleagues that support the assembly and shipping of our products to the EMEA market. This role will be based in Waterford and will report to the Assembly Centre Team Lead.
Responsibilities:
What Repligen Offers:
We are on the lookout for a QC Inspector to support our expanding European Asembley Cenre
We are a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs.
You’ll be part of a cross functional team of 10-12 highly motivated and collaborative colleagues that support the assembly and shipping of our products to the EMEA market. This role will be based in Waterford and will report to the Assembly Centre Team Lead.
As the QC Inspector you will be responsible for
- Compliance with quality standards / procedures / policies / SOP’s and all other approved documentation.
- Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished Flow Kit products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements.
- Perform functional testing of more complex finished systems using both automated and manual valve testing equipment to ensure conformance with design specifications
- Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks
- Perform line clearance and verification of inspection
- Perform verification of manufacturing documents with Manufacturing Specifications as Outlined in FP01 and device drawings
- Support the training and Qualification of other Quality Inspectors & Production Operators through work demonstration and feedback and use of Gage R&R Studies.
- Use / storage / processing / control of materials within relevant areas in the manufacturing operations dept. as per relevant approved documentation including SOP’s / Batch Documents /MO’s/Mfg. Drawings etc.
- Support of operational targets including but not limited to Efficiency / Right First Time (Rework) / Final Pass Yield (Scrap)/ Doc Error.
- Involvement and active participation with Continuous improvement projects to improve Quality and Efficiency of the Manufacturing Process.
- Complete and Thorough knowledge of Areas of expertise in Terms of Moulding Process, In Process Inspection, Assembly and Packaging as agreed by Shift Training Versatility Goals.
- Maintaining and control of specialised equipment and tools in relevant areas as per applicable SOP’s
- Completion of all Manufacturing and Packaging in process testing as per approved Documentation / SOP's / Batch Documents / Policies
- Other duties may be assigned on discretionary basis as required by new developments or changes to the role.
- GMP and GDP Experience is Preferable, but training will be provided for the Role.
- Leaving Certificate or equivalent
- 1 year quality control experience
What Repligen Offers:
Repligen offers you a competitive remuneration package, including a yearly bonus, private medical insurance and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waterford, Ireland.
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