QC Analyst – Quality Operations Laboratory Join a growing and collaborative Quality Operations Laboratory team supporting the analysis of biologics, vaccines, and pharmaceutical products within a modern, highly regulated manufacturing environment. This role offers the opportunity to work in a state‑of‑the‑art facility focused on commercial testing, analytical method transfer, and validation activities. The QC Analyst / Senior QC Technician will report to the QC Manager and play a key role in laboratory expansion, routine testing, and ensuring compliance with GMP and quality standards. Shift Patterns This role operates on two different shift models , and positions are available across both: 2-Cycle Shift (e.g. days/evenings rotation) 4-Cycle Shift (including days, nights, and weekends) Flexibility for shift work is essential. Key Responsibilities Perform laboratory testing in accordance with cGMP, cGLP, and site procedures. Execute analytical testing using techniques such as HPLC (HIC, IEX, HP-SEC), Capillary Electrophoresis , and compendial methods. Support analytical method transfer, validation, and routine commercial testing . Accurately complete and review laboratory documentation ensuring data integrity (ALCOA+) and Right First Time (RFT) principles. Participate in Tier 1 meetings , communicating testing progress, deviations, and issues. Assist in OOS (Out of Specification) investigations and laboratory deviations. Contribute to SOP writing, revision, and training documentation . Support audit and inspection readiness , including participation as an auditee. Drive continuous improvement initiatives , including root cause analysis (e.g. 5 Whys, Fishbone, FMEA). Work collaboratively with cross-functional teams to maintain a safe, compliant, and high-performing laboratory environment. Requirements Bachelor’s Degree (or higher) in Analytical Chemistry, Biochemistry , or a related scientific discipline. 3-4 years’ experience in a GMP-regulated pharmaceutical laboratory. Hands‑on experience with HPLC systems and associated software is strongly preferred. Good understanding of cGMP, GLP, and Quality Management Systems . Experience with laboratory investigations, LIMS, and documentation practices is desirable. Strong attention to detail, problem‑solving skills, and ability to work in a team environment. Additional Information Occasional travel may be required for training or project support. Opportunity to work in a highly advanced manufacturing and laboratory environment. Strong focus on employee development, collaboration, and continuous improvement. Key Skills Analytical Method Transfer GMP Compliance & Laboratory Operations HPLC & Analytical Techniques LIMS & Data Integrity OOS & Deviation Investigations SOPs & Technical Documentation Quality Control & Testing #J-18808-Ljbffr
Quality Control Analyst – Biochemistry & Cell Biology Location: Dunboyne, Co. Meath (Onsite) Shift: Day Role Role Overview An opportunity to join a state-of-the-art, single-use, multi-product biotech facility supporting Quality Control laboratory operations. The role operates within a self-directed team environment, contributing to analytical testing, compliance, and continuous improvement initiatives. The QC Analyst will be responsible for performing biochemical and cell biology testing to support in-process, drug substance, drug product, and stability testing in full compliance with cGMP and regulatory standards. Key Responsibilities Perform routine analytical testing using techniques such as ELISA, PCR, Bioassays , Cell Culture, and compendial methods. Execute testing for in-process, drug substance, drug product, validation, and stability samples . Review and approve analytical data ensuring data integrity (ALCOA+) and GMP compliance . Support analytical method transfer, verification, and validation activities . Maintain audit readiness and support inspections. Participate in deviation investigations, OOS/OOT events, and CAPA activities . Operate, calibrate, qualify, and troubleshoot laboratory equipment. Ensure accurate GMP documentation, SOP adherence, and training compliance . Drive continuous improvement initiatives and root cause analysis . Collaborate with cross-functional teams (QA, QC, Manufacturing, Engineering) . Adhere to EHS, GMP, and site safety standards . Key Requirements Degree in Science, Biochemistry, Biology, or a related discipline . Minimum 3-5 years of experience in a GMP-regulated laboratory environment . Ideally hands-on experience in Bioassays and PCR techniques . Strong knowledge of cGMP, GLP, and Quality Management Systems . Experience with analytical testing, data review, and documentation . Knowledge of method validation, method transfer, and laboratory investigations (OOS/OOT) . Strong problem-solving, communication, and teamwork skills . Ability to work independently and manage multiple priorities effectively. Exposure to Lean / Continuous Improvement tools (desirable) . Additional Information Fully onsite role in Dunboyne . Day shift position . Opportunity to work in a high-performing, collaborative biotech environment . #J-18808-Ljbffr
Independent Solutions is seeking a Manufacturing Biotech Associate (BTA) in Dunboyne, County Meath. This position involves executing manufacturing operations in a biologics facility, ensuring compliance with GMP standards, and driving continuous improvement initiatives. The ideal candidate will have a Level 7 qualification in Science or Engineering and proven GMP experience. The role offers opportunities to mentor team members and participate in comprehensive production processes in a fast-paced environment. #J-18808-Ljbffr
Job Title: Manufacturing Biotech Associate (BTA) – Level O3 Purpose of the Role This position is based at a state-of-the-art biologics manufacturing facility supporting the production of drug substances for clinical supply, regulatory approval, and commercial launch. The site operates in a multi-product environment, requiring flexibility to adapt to evolving pipeline needs. The Manufacturing Biotech Associate (BTA) is responsible for executing manufacturing operations on a designated shift, covering both upstream and downstream processes such as inoculation, cell culture, filtration, and purification using advanced, single-use technologies. This role also involves working with automated and paperless systems, ensuring all manufacturing activities are completed in compliance with GMP and EHS standards. In addition, the BTA will play a key role in driving continuous improvement, mentoring team members, and supporting operational excellence initiatives to ensure consistent delivery of key performance indicators (KPIs). Key Responsibilities Support and execute end-to-end biologics manufacturing operations. Operate equipment in accordance with electronic batch records (EBR), SOPs, and sampling plans. Ensure strict adherence to GMP, safety, and compliance standards. Perform upstream and downstream processing including cell culture, filtration, and purification. Set up and operate single-use systems between manufacturing runs. Complete and review manufacturing documentation in line with GMP requirements. Support delivery of KPIs including safety, quality, production targets, and OEE. Apply Lean Six Sigma tools to drive continuous improvement initiatives. Participate in troubleshooting, investigations (e.g., deviations, CAPAs), and issue resolution. Create, review, and update SOPs, work instructions, and training materials. Participate in internal audits and risk assessments. Support shift handovers and team meetings, ensuring clear communication of issues and actions. Act as a unit operation lead and take ownership of specific process areas. Coach and mentor team members on best practices, documentation, and production systems. Promote a strong safety culture and actively contribute to EHS initiatives. Ensure completion and review of batch records, SAP transactions, and electronic logs by end of shift. Required Education, Experience & Skills Level 7 qualification in Science, Engineering, or a related discipline. (Level 6 with 3+ years of GMP manufacturing experience will also be considered). Proven experience in a GMP manufacturing environment. Strong problem‑solving skills and ability to meet tight timelines. Experience leading or supporting cross‑functional teams. Hands‑on experience with automated systems such as MES (e.g., PAS‑X), SAP, and DeltaV. Knowledge of contamination control and batch release requirements. Experience with single‑use technologies. Understanding of upstream and downstream biologics manufacturing (e.g., mAbs). Ability to work effectively in a team‑based, fast‑paced environment. Preferred Skills & Experience Strong GMP manufacturing background in biologics. Experience with automation and digital manufacturing systems. Exposure to Lean manufacturing or continuous improvement methodologies. Additional Information Site-based role Requires flexibility to work a 24/7 shift pattern #J-18808-Ljbffr
