80 Quality Control Analyst jobs in Ireland

PE Global is currently recruiting for a Senior QC Analyst for a leading multi-national Medical Devices client based in Galway.

This is a contract position.

Role:

• Act as Subject matter expert and provide oversight for critical NPD areas:
• Dissolution/Elution (USP APPII/USP APPVII)
• Liquid/Gas Chromatography
• Analytical test method development
• Analytical test method validation
• Work independently to plan and schedule activities to meet project timelines
• · Author technical reports and validation documents
• · Provide guidance and communicate updates to cross-functional and cross-site teams
• · Support laboratory investigations to determine root cause and implement meaningful corrective actions
• · Drive continuous improvement projects to reduce testing lead-times and support cost saving targets
• · Supports Training of new colleagues
• · Supports Internal and External Audit programs
• Support Regulatory submissions

Requirements

• Bachelors degree in a science discipline

• 3-5 years experience in Medical Devices or related Industry

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Role Purpose:

• Our client based in Co. Waterford is looking for QC Analyst to join their busy biopharmaceutical facility.
• The function of this position is to provide his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies.

Core Duties and Responsibilities:

• QC Analyst (Controls and Standards) tasks include;
• Management of standards, controls and critical reagents in the QC laboratory
• Support with inter-site qualification and extension of controls and standards.
• Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
• Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chapters
• Preparation of qualification memo's in Veeva to support QC testing activities.
• Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
• Ensure compliance to cGMP at all times

Education & Qualifications Required:

• Higher Level degree in science or equivalent technical discipline
• 3years + experience within Pharmaceutical Development, Analytical and/or Manufacturing department
• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
• Ability to analyse complex data and laboratory results to make informed decisions and identify areas for improvement.
• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
• Flexible approach, comfortable with ongoing change and improvement in the organisation
• Ability to drive project deliverables/goals to closure
• Ability to work autonomously while maintaining communication with key stakeholders
• Ability to articulate issues and communicate at all levels, in particular with departmental management and program leads
• Willingness to take ownership for resolution of departmental and/or cross functional issues
• Strong team player with a creative and innovative approach
• Ability to interact effectively in multi-disciplinary teams
• Seeing tasks through to successful completion
• Excellent communicator and attention to detail
• Brings scientific rigour and discipline to approaches

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QC Bioanalytical Analyst

Start Date- ASAP

Location-Dublin-Ireland

Duration- 11 Months (FTC)

Pay rate- Euros 19/hr to 30/hr

Description-
QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory.

Role Functions-

• Perform and carry out a variety of routine analytical techniques, including but not limited to HPLC, Compendials, UV, Raw Materials, DNA PCR, and Bioassay ELISA testing in compliance with GMP requirements.
• Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations
  ,
  and industry standards.
• Support the laboratory testing schedule to achieve an efficient QC system.
• Receive and manage samples that come into the lab for stability, in-process
  ,
  and release testing.
• Reagent preparation, cleaning, and routine equipment maintenance.
• Maintain good housekeeping and hygiene within the laboratory.
• Calibrate and maintain all designated laboratory instruments.
• Participate in risk assessments, inspections, audits, incident investigations, etc.
  ,
  and implement and follow up on corrective/preventative measures.
• Ensure training is current for all job functions performed.
• Order, stock
  ,
  and receive laboratory supplies.
• Maintain data integrity and ensure compliance with company SOPs, specifications
  ,
  and cGMP regulations.
• Ensure that cGMP standards are always maintained.
• Promote and participate in the implementation and maintenance of the relevant safety programs.

Experience, Knowledge & Skills-

• 1 - 5 years of laboratory testing experience in the pharmaceutical industry.
• Relevant experience and skill set in their area of expertise that add value to the business; ideally in a manufacturing, preferably in a GMP setting.
• Experience and critical skills in the area of expertise that add value to the business; ideally, bioassay and DNA tests.
• Knowledge of regulatory/ code requirements to Irish, European, and International Codes, Standards, and Practices.
• Knowledge of cGMP & Laboratory Quality Systems.
• Effective communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.

Qualifications & Education-

Qualification in Science/Chemical Engineering/Biological Engineering.

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 Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• Performs QC assignments for quality systems, processes and controls.
• Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
• Responds to Operational and business area's, ensuring compliance with cGMP and corporate regulations.
• Support the performance of the site cGMP activities.

Responsibilities:

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable CGMP training.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
• Work collaboratively to ensure a safe and compliant culture
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• May be required to perform other duties as assigned.

Quality

• Liaise with the Quality/ Business Area Specialists/QC Leads) to resolve quality related queries where required.
• Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
• Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic products activities, in compliance with applicable procedures, our Company's Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing,, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.

Delivery:

• Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
• Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Acknowledge approved job description for the role.
• Support in resolving routine potential quality issues.
• Provide quality support of controls and procedures for the end to end material and product lifecycle where required.

Quality Control:

• Perform laboratory testing and / or materials inspections to determine specification conformance.
• Perform all required analytical, microbiological and control testing to support the site.
• Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.

Compliance Responsibilities:

• Execute/Review /Support deviation/ CAPA activities, complaints, data integrity, Material Qualification, Validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and supporting trending where required for the Quality department and supporting functions.
• Ensure compliance to regulatory requirements.
• Review of all manufacturing batch/ material documentation including (but not limited to) electronic batch records, real time reports, master data using the Quality (Control) systems where required.
• Review of, SOP's, GMP data and other documents as necessary for the Quality department where required
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.

Other:

• Participate in training programs & provide training to other team members as required.
• Provide quality support to the qualification/validation, technical transfers and commercial operations at the facility where required.
• Applies knowledge and skills to other areas within product/ department; may act as a source of technical expertise for others.
• Identifies and solves problems.
• Acknowledge approved job description for the role.
• Respond to and resolve routine potential quality issues by providing quality compliance guidance, expertise & critical thinking.
• Provide quality support to the qualification/validation, technical transfers, and commercial operations at the facility where required.
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
• Applies knowledge and skills to other areas within product/department ; provides technical guidance and training to others.
• Anticipates and solves complex production/operational problems.
• Participate in internal and external audits and inspections, ensuring department compliance/readiness.

Education:

• Bachelors Degree or higher preferred; ideally in a related Science discipline

An excellent opportunity for a QC Analyst with 1 - 2 years analytical testing experience within a cGMP regulated pharmaceutical lab. significant experience performing HPLC, KF, FTIR required. Experience working with raw materials within a pharmaceutical company is preferred.

** 12 month contract located in North Dublin.

Responsibilities will include (but not limited to):

• Performing QC testing (TOC, pH Conductivity) of water samples. Performing analysis of Raw Materials including HPLC, KF, UV, IR and wet chemistry techniques. Completion in a timely and accurate manner of laboratory documentation as directed by the QC Manager.
• Assisting in updating and issuing documentation, including SOPs, as required.
• Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports.
• Accurately documenting laboratory work.
• Execute and assist in technical transfer and co-validation activities.
• Sample management activities- ensuring chain of custody is maintained using CIMS and LIMS
• Assisting with qualification of laboratory instruments.
• Data review based on demonstrated proficiency on assays.

Qualifications and Experience required:

• Previous experience performing QC testing within a regulated pharmaceutical or biopharmaceutical laboratory is required.
• experience performing HPLC, KF, FTIR, wet chemistry tests within the pharmaceutical industry.
• Proficient user of Empower software.
• BSc. in Science/Chemistry/Biochemistry or related discipline.
• The successful candidate must demonstrate an ability to work independently and recognize anomalous trends or results.
• Must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines.
• Excellent communication and the ability to work in a team based collaborative environment are required.

Role:
QC Material Management Analyst

Role Location:
North Dublin

Role Type:
12 month contract

We are seeking to recruit a QC Material Management Analyst to join the QC Site Operations team at a Multi-Product Cell Culture Drug Substance Facility in North Dublin

Reporting to the QC Material Management Supervisor, you will be responsible for supporting site activities related to performing testing of Raw Materials, in-process samples and laboratory duties in accordance with cGMP regulations.

The main responsibilities for this position include;

· Performing QC testing (TOC, pH Conductivity) of water samples. Performing analysis of Raw Materials including HPLC, KF, UV, IR and wet chemistry techniques. Completion in a timely and accurate manner of laboratory documentation as directed by the QC Material Management Supervisor.

· Compliance with Standard Operating Procedures and Registered Specifications.

· Assisting in authoring and reviewing documentation, including SOPs, as required.

· Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures.

· Supporting technical transfer of new projects.

· Assisting with out of specification investigations and deviations using the Infinity system.

· Sample management activities- ensuring chain of custody is maintained using CIMS and LIMS.

· Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.

· Performing any other activities as indicated by the Lab Supervisor.

The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work in a team based collaborative environment.

The ideal candidate should hold a minimum of a third level qualification (Degree) in Chemistry/Biology or related discipline along with at least 2-3 year of experience in a pharmaceutical / healthcare laboratory or related technical function.

QC Analyst

• North Dublin
• Permanent opportunity
• Clear progression trajectories internally

Background

Our client is seeking a QC Analyst with 1+ years experience to join the team during a period of internal development Reporting to the QC Supervisor, you will have the opportunity to troubleshoot hi-tech laboratory instrumentation, complete formulation R&D studies, PLUS MORE

What's on Offer?

• Competitive salary with full benefits (pension, healthcare AND MORE)
• Flexibility - Half day of YOUR CHOICE every week
• Clearly outlined and proven progression trajectories internally

Key Responsibilities

• Conduct QC analysis
• Assist in technical investigations related to product quality
• Troubleshooting activities for instrumentation including High-Performance Liquid Chromatography (HPLC)
• Documentation activities including updating of SOPs and protocols where required.

Key Skills Required

• BSc in Scientific related discipline - chemistry focus preferable
• 1+ years experience working in a GMP lab environment
• Hands on experience working with HPLC and other laboratory instrumentation

Catalyx is seeking a QC Analyst to join our team and work on our customer site in Waterford.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit

.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

The successful candidate will be responsible for isolating particles from sterile biologics and supporting investigations into particle origin. The role will involve use of advanced analytical techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy.

Responsibilities:

• Provide analytical chemistry services and support to site operations.
• Perform particle analysis and support investigations into the source of foreign matter.
• Collaborate effectively with Quality Assurance, Production, Engineering, and Planning departments.
• Maintain, update, and issue chemical methods, specifications, and SOPs in line with regulatory and pharmacopoeial requirements.
• Train analysts in relevant methods, SOPs, and technical updates.
• Monitor and trend analytical results, complete COAs, and support OOS investigations.
• Ensure all laboratory records and documentation are accurate, current, and compliant.
• Ensure QC laboratories operate in compliance with current Good Laboratory Practice (cGLP).
• Verify that chemical testing and related equipment meet validation requirements (IQ, OQ, PQ).
• Review and audit laboratory notebooks, analytical reports, and chemistry test results to ensure compliance with cGLP and cGMP.
• Identify potential issues and highlight improvements to the QC Team Lead.

Requirements:

• Degree in Chemistry, Analytical Science, or a related discipline.
• Experience in analytical testing within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Hands-on expertise with particle characterisation techniques such as FTIR, Raman spectroscopy, and SEM.
• Strong knowledge of cGMP and cGLP requirements.
• Familiarity with method development, validation, and maintenance of SOPs and technical documentation.
• Ability to conduct and support OOS and deviation investigations.
• Strong communication and collaboration skills, with the ability to work across multidisciplinary teams.
• Detail-oriented, self-motivated, and adaptable.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

Position: QC Analyst this role is based in Phoenix Healthcare, Unit 31, Second Ave, Cookstown, Dublin, D24 TP60

Job description

The company is unable to sponsor visas for candidates.

Key Responsibilities:

• Perform precise sampling of incoming raw materials in accordance with established protocols and SOPs.
• Conduct chemical, physical, and (if necessary) microbiological tests on raw materials using analytical techniques such as:
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Ultraviolet-Visible Spectroscopy (UV-VIS)
• Fourier-Transform Infrared Spectroscopy (FTIR)
• Titration, pH measurements, moisture analysis, and other relevant techniques.
• Compare test results against established specifications and ensure materials meet required quality standards before approval.
• Accurately record all test results in laboratory notebooks or data management systems such as LIMS.
• Review and verify supplier Certificates of Analysis (CoAs) to ensure conformity with internal quality standards.
• Issue reports on material quality and prepare internal Certificates of Analysis (CoAs) when necessary.
• Ensure raw material testing adheres to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines.
• Flag and report any non-conforming materials and deviations from specifications, initiating investigation processes where required.
• Work closely with procurement and supply chain teams to ensure raw material suppliers adhere to quality requirements and specifications.
• Communicate any material quality issues with suppliers and participate in supplier quality assessments and audits as needed.
• Collaborate with warehouse teams to ensure proper sampling and storage of raw materials.
• Regularly calibrate and maintain lab equipment such as HPLC, GC, and other instruments to ensure accurate test results.
• Troubleshoot equipment malfunctions and coordinate repairs or service when needed.
• Perform routine testing using techniques such as HPLC, GC, UV-VIS, and FTIR to analyse raw materials, in-process products, and finished goods.

Qualifications:

• Education
  :

Bachelor's degree in chemistry, Biochemistry, Microbiology, or related field.

• Experience
  :

o 2+ years of experience in a QC lab, preferably in pharmaceuticals, cosmetics, or FMCG.

o Hands-on experience with analytical instruments (HPLC, GC, FTIR) and familiarity with GMP/GLP.

• Skills
  :

o Strong attention to detail and ability to follow SOPs.

o Excellent written and verbal communication skills.

o Proficiency in data management systems (e.g., LIMS) and statistical analysis tools.