Job Description
A fantatstic opportunity for a QC Micro Analyst with 2 years' pharmaceutical industry experience to join the team at a leading bio-pharma company in Cork on a 2 cycle or 4 cycle shift pattern for 12 months. 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 is desired for this role Duties include: 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. 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. Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc. Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc. Preferred experience in: Bioburden Endotoxin Sterility Testing Microbial Identification using genetic methods Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise desired. Qualifications & Experience: Third-level qualification (Minimum: Primary degree in a science discipline). A minimum of 2 years experience within the Pharmaceutical Industry Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products. Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative. BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES. Skills: Microbiology Bioburden Sterility Endotoxin Analytical testing API