Lead QC Micro (Operations) Analyst II-IV
Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged. Summary . Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities. Lead-Related Activities include, but are not limited to, the following . Provides on-the-floor guidance and support to employees . Ensures employees timesheets are completed on time . Monitors employees training to ensure that all requirements are met, including OJT . Maintain up to date training records for self and direct reports . Perform monthly performance feedback meetings with direct reports . Escalates all performance issues to management and/or HR. Essential Duties and Responsibilities include, but are not limited to, the following . Supports Product Testing and environmental monitoring sampling . Microbiology representation and participation in cross functional site meetings . Administration of programs such as gowning, training, ordering, calibration, etc . Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc . Participates in training of other new employees and prioritizes daily workload . Performs peer review of data . Performs laboratory investigation reports . Maintains laboratory supplies, media, and reagents inventory . Participates in the overtime and weekend schedule as required . Updates microbiological environmental monitoring results database and prepares monthly report . Performs acceptance testing of commercially prepared microbiological culture media . Assists in coordinating equipment maintenance and calibration . Uses Laboratory Information Management System LIMS for sample and sample test result tracking . Performs all duties relevant to the Quality Control Microbiology Analyst position as required . Education and Experience . A third level qualification BSc degree or higher in Microbiology or related field. Will substitute relevant work experience in lieu of degree requirement . Requires 2+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry . Excellent communication skills, both verbal & written . Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc , is an advantage . Adaptable and flexible, as position may require some travel . Collaboration and team work. Maintains the highest standards of ethical behaviour . Results and performance driven . Strong analytical ability and associated problem solving . Good time management and attention to detail . Knowledge and proficient in the use of Microsoft products including, Project, Excel, Word and PowerPoint. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.