Cache of job #13941702

Job Title

QC Analyst - Cork

Employer

Pe Global

Location

Cork

Description

PE Global is currently recruiting for a QC Analyst for Bio client in Cork : SUMMARY DESCRIPTION. Our client’s high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions have an opening for a QC Analyst. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills. Reporting to the QC Team Leader, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Ensuring our products are safe for patient use and fit for purpose. The team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process. The role could potentially lie within any of these sub-teams depending on experience and requirement. Shift work may be required. The role potentially will cover both Analytical and Microbiological testing including but not limited to the following: Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs. Analytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis. Testing of finished product, raw materials, packaging and stability. Perform primary review of QC raw data and trend results. Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies. Develop, optimize, validate and troubleshoot analytical test methods. Draft QC SOPs. Act as technical resource (SME)and train other analysts in areas of expertise. Evaluate results against defined acceptance criteria. Conduct and document laboratory investigations to completion. Maintain the laboratory in an inspection-ready state. Interact directly with regulatory agency inspectors during audits. Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary. Excellent communication skills both written and verbal. Customer focus; takes personal responsibility for speed; quality and accuracy of delivery. Self-motivated and ability to work under pressure. Team Leadership – active participation team development and continuous improvement including standard work and 5S. Successful track record in achieving goals as part of a team within a growing, dynamic environment. Demonstrated adaptability and flexibility to support a growing organisation. Skills: Ability to work independently and meeting established timelines. Comfort with coordinating the activities with other staff members. Comfort with working in a team environment. Knowledge of cGMPs. Education: B.S. in a scientific discipline with 3+ years of relevant laboratory experience. Interested candidates should submit an updated CV, marked for the attention of Audrey. audrey.brennan@peglobal.net or 00353 21 4297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

Date Added

2017 days ago

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