Job Description
Description: PE Global is currently recruiting for a QC Micro Analyst on behalf of a leading biotech company based in Cork. This is an initial 12-month contract and a 2-shift cycle role. Overview: The candidate must have superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product. The candidate must have prior experience of working in an IMB/FDA regulated facility. Responsibilities: Reporting to the QC Team Leader Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release. Rapid turnaround of samples to meet manufacturing needs. Performing data review and approval. Providing support and advice to manufacturing on QC related topics. Initiating and leading investigations where required. Initiates and completes, CAPAs and Change Controls in accordance with site procedure Writes new and updates current procedures on electronic documentation system. Providing training to other analysts and to manufacturing personnel. Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc. Proactively identifies and implements lab process improvements. Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc. Supports Team leader on day to day testing operations SPECIFIC TESTING EXPERIENCE REQUIRED Bioburden Endotoxin Sterility testing Microbial Identification using genetic methods Education and Experience: BSc (Honors) in a scientific/technical discipline. A minimum of 2 years experience within the Pharmaceutical Industry Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products. Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** 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. Skills: microbiology endotoxin bioburden environmental monitoring