Specialist - QC Separation Sciences
3 hours ago
Overview: This job specification outlines the general responsibilities associated with the role of QC Separation Sciences - Technical Specialist at the Amgen Manufacturing site. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a role model for other lab colleagues. The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role. Key Responsibilities SME in a variety of analytical techniques including but not limited to HPLC, HIC, CE, UPLC and Mass Spectroscopy Plan and perform multiple, complex routine/ non-routine methods Responsible for providing technical guidance and applying expertise and critical thinking to independently resolve technical issues Lead training of staff on technical aspects of job as required Develop, revise and implement procedures that comply with appropriate regulatory requirements Experience of managing project groups and leading high performing teams and delivering results Qualification of analytical equipment and related testing functions Co-ordinates & plans activities related to the successful method transfers and optimisation of Separation Methods into the Amgen site Compliance with Standard Operating Procedures and Registered specifications Ensure the laboratory is operated in a safe manner Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP. Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications Participate in regulatory agency inspections as required Plan and implement procedures and systems to maximise operating efficiency Manage and contribute to the achievements of department productivity and quality goals Act as a change agent in support of continuous improvement Basic Qualifications: Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline. 7+ years of experience in a pharmaceutical/healthcare Laboratory Proven experience of leading teams Strong background in Separation techniques e.g. HPLC, CE and Gel Electrophoresis UPLC and Mass Spectroscopy experience advantageous Analytical Technical Transfer experience essential Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating Preferred Qualifications: Excellent written and verbal communication skills Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage Knowledge of applicable Regulatory requirements Experience with Regulatory inspections and interacting with inspectors Experience leading cross-functional teams Experience working with teams and influencing decision making Skilled in the use of problem solving tools/techniques To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
-
Dublin, Ireland Amgen Full timeOverview: This job specification outlines the general responsibilities associated with the role of QC Separation Sciences - Technical Specialist at the Amgen Manufacturing site. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a...
-
QC Instrumentation Specialist
2 weeks ago
Dublin, Ireland Headcount Solutions Limited Full timeQC Instrumentation Senior SpecialistSeeking to recruit a QC Instrumentation Senior Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. The specialist will manage the purchase and qualification of laboratory instruments and will be responsible for providing an Instrument Calibration and Maintenance...
-
▷ (Urgent) QC Instrumentation Specialist
2 weeks ago
Dublin, Ireland PSC Biotech Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
QC Specialist
2 weeks ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeQC Instrumentation Senior Specialist - Dublin, Ireland - 12-Month Contract One of the top 10 best companies to work in Ireland is looking for more engineers for their large-scale new facility north of Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion...
-
QC Bioanalytical Sciences Senior Associate
15 hours ago
Dublin, Ireland Life Science Recruitment Ltd Full timeWere currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. QC Bioanalytical Sciences Senior Associate will be responsible for leading, coordinating, facilitating, and...
-
QC Bioanalytical Sciences Senior Associate
4 hours ago
Dublin, Ireland Life Science Recruitment Ltd Full timeWere currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. QC Bioanalytical Sciences Senior Associate will be responsible for leading, coordinating, facilitating, and...
-
Dublin, Ireland PSC Biotech Corporation Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
QC BioAnalytical Sciences – Senior Associate
4 days ago
Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a QC BioAnalytical Sciences - Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 2 years of experience years in construction management/engineering within in the pharmaceutical or...
-
QC BioAnalytical Sciences
3 hours ago
Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a QC BioAnalytical Sciences - Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 2 years of experience years in construction management/engineering within in the pharmaceutical or...
-
Sr. Associate QC
15 hours ago
Dublin, Ireland Amgen Full timeQuality Control NPI Snr Associate Level 4 Amgen Dun Laoghaire Primary Responsibilities: QC Representative for NPI activities and routine Product meetings Assist with activities related to QC projects and/or QC tasks within Site projects Plan and perform non-core testing related to NPI activities Manage all sample management activities related to NPI...
-
Sr. Associate QC
4 hours ago
Dublin, Ireland Amgen Full timeQuality Control NPI Snr Associate Level 4 Amgen Dun Laoghaire Primary Responsibilities: QC Representative for NPI activities and routine Product meetings Assist with activities related to QC projects and/or QC tasks within Site projects Plan and perform non-core testing related to NPI activities Manage all sample management activities related to NPI...
-
▷ Apply Now! QC Bioanalytical Analyst
2 weeks ago
Dublin, Ireland PSC Biotech Corporation Full timeJob Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
(1/18/2025 A) QC Microbiology Analyst
2 weeks ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeQC Microbiology Analyst - Contract - Biopharmaceutical - Dublin As Dublin continues to embed itself as Ireland's Pharmaceutical capital, we are seeking a QC Microbiology Analyst to become part of a state-of-the-art bio facility. In this position, you will be responsible for supporting the Bulk Drug Facility in Dublin with emphasis on microbiological testing...
-
QC Team Lead
3 hours ago
Dublin, Ireland Cpl Resources Full timeQuality Control Team Lead (Raw Materials) SK pharmtecoare seeking to recruit a Quality Control Team Lead (Raw Materials) to join the QC Department based in Swords, Co. Dublin on a permanent basis. About the company SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and...
-
QC Lab Systems Specialist
22 hours ago
Dublin North, Ireland Morgan McKinley Full timeRole Overview: This position is a technical support role within the Lab Digital Sciences organization QC Digital Systems Technical Support pillar that is responsible for building and maintain LIMS master data, following developed standards in direct support of Global Quality Control Operations that are responsible for testing to support new product...
-
Vice President, Head of Analytical Sciences
2 weeks ago
Dublin, Ireland BIOMARIN Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using...
-
Vice President, Head of Analytical Sciences
2 weeks ago
Dublin, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
Vice President, Head of Analytical Sciences
2 days ago
Dublin, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
Senior Specialist in Analytical Science
2 weeks ago
Dublin, Ireland PSC Biotech Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
QC Analyst
2 weeks ago
Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with our Client Pfizer are seeking QC Analyst in Chemistry divisions to join the team at their state of the art site in Dublin, Grange Castle for a contingent fixed term contract. This is an on site role. What You Will Achieve: You will be a member of Pfizer’s dedicated and highly effective quality control team. You will be responsible...
