Job Overview Orion Group Life Sciences is currently recruiting a QC Micro Technician on behalf of our Multinational Biopharma client based in Carlow on an initial 11‑month contract with potential to extend. Shift role. Shift patterns are as follows: 2‑cycle shift: Monday – Friday, 07:00‑15:00 and 14:45‑22:45 Weekend shift: Week 1: Mon & Tues 07:00‑17:00; Friday 07:00‑17:00; Saturday & Sunday 12‑hour shift 07:00‑21:00 Week 2: Wed & Thu 07:00‑19:00; 20% shift premium. Responsibilities Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day‑to‑day business activities. Perform laboratory testing to determine specification conformance and to support site targets, including but not limited to bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Maintain an adequate, qualified, and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Contribute to effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various quality‑related systems. Highlight any discrepancies, deviations, or non‑conformance in testing or work practices and support investigations as required. Ensure compliance with GMP and EHS guidelines at all times. Participate in training programs as required. Qualifications Required Minimum of a Bachelor’s Degree or higher in a related science discipline. 1‑2 years’ experience in a GMP laboratory environment. Good knowledge of GMP, GLP, and aseptic technique. Proficient computer skills and technical writing. Strong interpersonal and communication skills. Preferred Experience in a microbiology laboratory setting. Familiarity with bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. #J-18808-Ljbffr
Orion Group is seeking a QC Micro Technician for a multinational biopharma client in Carlow. This initial 11-month contract role involves ensuring compliance with data integrity principles, performing laboratory testing, and maintaining a compliant laboratory environment. Candidates should have a Bachelor’s Degree in a related science, with 1-2 years of GMP experience preferred. Strong communication skills and proficiency in technical writing are essential. A shift work pattern is required, offering varied hours including weekends. #J-18808-Ljbffr
Responsibilities Co-ordinate and/or execute internal and external review and approval of all Laboratory related documentation. Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP’s. Be a reliable point of contact for the laboratory area for clear and precise communication of the documentation process and status of documents. To co-ordinate processing of laboratory documents into and out-of ABB Documentation systems. A key member on the laboratory readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the laboratory documents are prepared, executed and post approved in line with best practices and relevant timelines. Ensure highest Quality & Compliance standards. Track and trend relevant laboratory and business process metrics to ensure the laboratory are performing effectively and efficiently. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Support the generation of efficient, user friendly documentation including SOPs. Assist in the preparation of progress reports/presentations as required. Revise, update, and format documentation including SOPs, forms, logbooks. Write/review laboratory documentation (SOPs & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements. Will act as an SME for the laboratory function and also the wider organization in adherence to GDP guidelines. Will be flexible to take on additional tasks and responsibilities at the discretion of their manager. Applies knowledge, experience, and technical skills to understand laboratory objectives, to provide support to laboratory initiatives, to execute processes and procedures efficiently and compliantly, evaluates documents for improvement potential. Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the laboratory department. Schedules and execute tasks, with limited assistance, to support laboratory schedule timelines. Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinate referrals across the cross functional groups. Manages document review and approval to meet schedule timelines. Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan. Investigates Documentation related events in production that have quality or compliance impact. Leads or participates IIA, RCI sessions. Documents investigation outcomes. Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Comply with AbbVie policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements. Manage the laboratory Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting. Requirements Bachelor’s Degree or equivalent preferential, preferably in a Science or related field Experience Level = 1+ Years Experience in a regulated laboratory setting. Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred. Expertise with Microsoft Word with a solid understanding of the review and formatting tools is required. Expertise with Outlook, Visio, Excel, and PowerPoint is required. Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required. Experience with the use of electronic systems to manage, edit and control documents is preferred. A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards Previous experience in a fast-paced and deadline driven environment is required. #J-18808-Ljbffr
Orion Group is seeking a Document Control Specialist in Sligo to manage laboratory documentation in compliance with cGMP. The ideal candidate will coordinate reviews, maintain high-quality standards, and manage document workflows efficiently. Responsibilities include document preparation, compliance checks, and reporting metrics. Applicants should hold a Bachelor’s Degree in a relevant field and possess experience in a regulated laboratory setting, with strong expertise in Microsoft Office tools. #J-18808-Ljbffr
