69 Qc Staff jobs in Ireland

Due to continued growth my client wishes to recruit a QC Tester Cork Key Responsibilities: Fully qualified Electrician with current Safe Electric (RECI) Certification. Verification & Certification (QC) License from a recognized Irish training authority. Proven experience in electrical testing, ideally in a pharmaceutical or similarly regulated industry. Knowledge of Irish regulations, GMP, and pharmaceutical plant standards. Strong attention to detail, excellent documentation abilities, and ability to work independently. Specific Requirements Medium Voltage (MV) experience Large scale pharmaceutical or data centre experience Electrical testing experience Driving Licence Willing to travel IPAF MEWP Licence QC Testing number Formal Electrical trade qualification (Certification required) 3-5 Years Experience Safepass and Manual handling training At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: MV experience pharmaceutical or data centre exp. diving license SafePass Manual handling. Benefits: Work From Home

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X ( . 
**Why join us?**
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees.
We're looking for a Shift QC Lead to support quality operations on the production floor. You'll lead non-conformance investigations, support lot disposition, and raise Quality Notifications. The role ensures corrective actions are completed and verified for assembly processes. You'll also provide QA support to the Shift Manager as needed.
**_This role is a shift role supporting our 4 Cycle Production schedule. This means 2 days ( 7am-7pm) and then 2 nights (7pm -7am)._**
**Responsibilities:**
+ Managing the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment.
+ Preparation of relevant work sheets and execution of In Process inspection tests
+ Packaging Line clearance verification.
+ Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process.
+ Review In process controls, SOP's, Test Methods and specifications to ensure Lab inspections are being carried out as per design intent.
+ Analysis of data, quality metrics and trends of in-process inspection data.
+ Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
+ Preparation, review and approval of technical documentation.
+ Perform training as required in the area.
+ Ensure the smooth running of functions under your control.
+ Any other reasonable duties which may be required by Quality management from time to time.
+ Ensure testing equipment is functioning properly and call for repairs where equipment is faulty.
+ Ability to Work in a cross functional team under the supervision of the Senior Quality Engineer.
+ Identify areas for quality control improvement and implement new methods accordingly.
+ Communicate quality or compliance concerns with urgency.
**Educational Requirements:**
+ Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance
**Relevant Experience:**
+ 2 - 3 years' previous experience within similar role.
+ Good knowledge and application ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards.
+ Good experience in the preparation of Technical Documentation.
+ Good knowledge of Statistical Process Control and sampling techniques and standards.
+ Good knowledge of SAP and Trackwise.
+ Good experience in presenting and preparation of supporting documentation for site MRB meetings.
+ A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory).
+ Proven ability of working in a cross-functional team environment.
+ Excellent interpersonal and communication skills.
+ High level of computer literacy.
Regular
embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Current Need The Quality team are seeking to recruit a Quality Control Senior Analyst to join the QC Department reporting to the QC Team Lead. Position Description: Reporting to the QC Team Lead, the successful candidate will be involved in the testing, review and release of raw materials, intermediates, and active pharmaceutical ingredients, in the Quality Control Laboratory. The QC Senior Analyst will: Provide technical support for instrumentation and analytical methodology and execute trouble- shooting. Provide coaching and training for instrumentation and analytical methodology within the QC laboratory. Plan and approve materials to meeting shipping and production timelines, stability timelines and Quality Control metrics. Co-ordinate and lead laboratory/site investigations. Identify and investigate out of trend / adverse results present in analytical results. Working as part of a Lean Lab team-based structure, the QC Senior Analyst will require excellent interpersonal and communication skills. The role will involve the use of the classical analytical technologies including Raman, FTIR, KF, in addition to a broad range of modern analytical techniques including HPLC, GC, ICP-AES, ICPMS, and wet chemistry techniques. The QC Senior Analyst will also be required to engage and fully participate in daily huddle meetings and short interval control boards. Minimum Requirements: BSc in Analytical Science, Chemistry or related discipline is required Minimum of 3 years experience in analytical chemistry is required. The desired candidate should be highly motivated, have strong teamwork skills, with proven success working in a team environment with flexibility to react to changing business needs. Experience in Operational Excellence, 5s, Lean Labs, yellow belt certification and yellow belt projects is desirable. The successful candidate will have a strong ability to manage their own workload and will play an important part in the various sub teams in QC such as Safety, Equipment, or Audit Readiness. Other Benefits include: Excellent opportunities for career enhancement and personal development Competitive base salary Annual bonus linked to business results A well-established further education program. Pension scheme Private Healthcare Insurance Skills: HPLC GMP API IPC QC Analytical Chemistry Method Development

Senior QC Associate (CMMS Maximo) - Hybrid RK4540 12 Months Dublin Were 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. The Senior QC Associate will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems in a cGMP Quality Control environment. Oversee tracking and management of activities through CMMS Maximo, authors and approves validation life cycle documents for computer-related systems, ensures data integrity compliance, and executes approved protocols. Duties: Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation. Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports. Conduct periodic reviews of instrument validation as part of validation life cycle. Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities. Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures. Where applicable, owns and project manages change controls and adherence to Change Control metrics Supporting and managing the addition of project components to CMMA Maximo Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems Any other tasks/projects assigned as per mangers request Education and Experience : Bachelors degree in a Science related field is required. Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments. Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing. Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity. Demonstrated success in managing an equipment qualification or maintenance program advantageous. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

Building Staff Solutions (BSS) are seeking applications for the position of QA/QC Junior in Tipperary.Our client is asuccessful Building and Civil Contractor Contractorwith a long history of completing projects on time, within budget and to the highest standards. The role of the QA/QC Junior is to monitor all site activity and report on observations. To collaborate with all disciplines to ensure Quality Assurance and implement Quality Control on Construction site What is required Your Responsibilities Reporting to QA/QC Manager Implementation of Company and client quality programs Audit, and inspect construction activities and monitor work in progress Ensure procedures are followed to provide traceability from initial order to field installation Maintenance of inspection and test plans Recommend and assist with preventative measures to ensure quality Create and present non-conformance reports Coordinate quality related activities with site owner quality staff, and assist with client expectations Review and process technical documents Assist with maintenance of project files and preparation of reports Participate in on-site safety meetings and be a leader of initiatives What you need to have ISO 9000 program experience considered an asset 1 year + of work experience in QA/QC related role, and industrial work environments Competent with Microsoft Office Motivated and confident, with excellent verbal and written communication skills High attention to detail Able to multi-task and meet strict deadlines Able to work towards goals and objectives with limited daily oversight What you get in return Excellent working environment A competitive package is on offer for the right candidate If you are interested in this role, Please click apply or contact Michael on today BSS will process the data you have provided to help us find you suitable employment and offer you opportunities to help further your career. As we are a recruitment agency you may be considered for multiple roles that are suitable to your experience. You can review our Privacy Notice here. JOB 45212 BSSCAT1 Skills: ISO 9001 Quality Control Quality Management

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. We're looking for a Shift QC Lead to support quality operations on the production floor. You'll lead non-conformance investigations, support lot disposition, and raise Quality Notifications. The role ensures corrective actions are completed and verified for assembly processes. You'll also provide QA support to the Shift Manager as needed. Responsibilities: Managing the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment. Preparation of relevant work sheets and execution of In Process inspection tests Packaging Line clearance verification. Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process. Review In process controls, SOP's, Test Methods and specifications to ensure Lab inspections are being carried out as per design intent. Analysis of data, quality metrics and trends of in-process inspection data. Liaise with relevant personnel regarding flow of product through QC department and other issues that arise. Preparation, review and approval of technical documentation. Perform training as required in the area. Ensure the smooth running of functions under your control. Any other reasonable duties which may be required by Quality management from time to time. Ensure testing equipment is functioning properly and call for repairs where equipment is faulty. Ability to Work in a cross functional team under the supervision of the Senior Quality Engineer. Identify areas for quality control improvement and implement new methods accordingly. Communicate quality or compliance concerns with urgency. Educational Requirements: Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance Relevant Experience: 2 - 3 years' previous experience within similar role. Good knowledge and application ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards. Good experience in the preparation of Technical Documentation. Good knowledge of Statistical Process Control and sampling techniques and standards. Good knowledge of SAP and Trackwise. Good experience in presenting and preparation of supporting documentation for site MRB meetings. A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory). Proven ability of working in a cross-functional team environment. Excellent interpersonal and communication skills. High level of computer literacy. Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

As a Compliance Specialist within QC you will support the QC organisation in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs. A typical day might include, but is not limited to, the following: Coordinating and managing preparation for regulatory inspections and internal audits, ensuring QC is audit ready at all times Acting as the primary QC point of contact during inspections or audits, addressing inquiries and providing documentation as needed Organizing and maintaining QC quality records, including Change Controls, CAPAs , and Workflows Leading cross-functional teams during Change Control or CAPA events, ensuring alignment on strategies and resolution plans Reviewing, editing and revising controlled documents to ensure compliance with written procedures and regulatory standards Monitoring open compliance records, such as CAPAs, Change Controls, and Workflows, to ensure timely resolution and closure Reporting quality system metrics to QC teams and other relevant departments to track performance and identify improvement areas Representing QC in interdepartmental teams and meetings, ensuring QC perspectives and requirements are considered Performing other duties assigned by QC management, demonstrating flexibility and a broad understanding of QC functions This role might be for you if: You thrive in a multifaceted and fast-paced environment You possess excellent verbal and written communication skills You enjoy collaboration with cross functional groups You successfully build and develop strategic partnerships You demonstrate an ability to work within a successful team To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent with 2+ years relevant experience, preferably in the pharmaceutical or biotechnology industries. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Responsibilities: The Senior Manager QC Microbiology is responsible for leading and managing the Micro and Environmental Monitoring teams. This role involves setting goals, managing performance, and providing clear direction in line with company goals, with safety as the foundation of all activities.
The Senior Manager is the key contact for microbiology-related activities for the site and network and leads the team during regulatory inspections, ensuring network alignment on commitments prior to agreement with agencies. They ensure that quality and compliance requirements are executed as established in the site's SOP and corporate guidelines, providing necessary coaching and guidance. The role requires managing multiple competing priorities, including site and functional responsibilities, frequent communications, and attending meetings as lead microbiologist on site. Most importantly they provide environmental compliance oversight to support aseptic production activities.
Skills and Competencies:
- Oral and Written Communication: Excellent listening skills and strong presentation skills, with the ability to describe technical information effectively throughout the organization
- Adaptability: Ability to deal with frequent change, delays, and unexpected events
- Continuous Improvement: Innovative and resourceful, with a focus on continuous improvement
- Collaboration: Excellent team and interpersonal skills
- Problem Solving: Proven record of problem-solving and decision-making skills
- Science-Based: Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
- Independent Decision Making: Exhibits sound and accurate judgment and knows when to escalate.
- Data Integrity: Strong knowledge and practices in data integrity
- Quality Management: Experience in managing and optimizing site EM Monitoring, Aseptic Technique training, and Gown qualification programs
- Regulatory Knowledge: Knowledge of safety, OSHA, and EPA regulations
- Technical Proficiency: Proficiency with Microsoft Word, Outlook, Excel, PowerPoint.
Qualifications:
- Education: Bachelor of Science degree in Microbiology, Biology or related science discipline
- Experience: Minimum of 10 years of related experience in GMP Aseptic or Sterile Manufacturing environment, working in Environmental Monitoring and/or Microbiology laboratory. Strong Environmental Monitoring management experience in a sterile manufacturing site is required. Knowledge of current trends in Aseptic Manufacturing standards and regulatory compliance requirements for Pharmaceutical/Biological manufacturing is preferred.
- Leadership: Demonstrated leadership and management skills, including establishing direction and goals, guiding execution, and fostering a team-based environment. Demonstrated mentoring and coaching, influencing, negotiating, and personal interaction skills.
Additional Information: The Senior Manager QC Microbiology plays a critical role in managing the QC Microbiology Release Testing and Environmental Monitoring laboratory. This department is responsible for testing products and monitoring the sterile manufacturing environment to ensure sterility assurance standards are met. The laboratory also supports New Product Introduction and Qualification activities related to manufacturing areas. The Senior Manager leads investigations, troubleshooting, and champions continuous improvement in their area.

**Overview:**
This job specification outlines the general responsibilities associated with the role of Manager QC Separation Sciences (QCSS) at Amgen Dun Laoghaire. This role will be responsible for managing the Separation Sciences team while owning, facilitating, and undertaking activities pertaining to QCSS within QC. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QCSS duties and testing, including release/stability/in process of commercial product. The role also represents the QC unit by liaising with internal and external stake holders
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
**Key Responsibilities:**
+ Supervision/Management of QC Separation Sciences including In-process team
+ Ensure the Separation Sciences area is operated in a safe manner
+ Ensure all testing is performed in accordance with relevant procedures and within the required due date.
+ Develop, revise and implement procedures that comply with appropriate regulatory requirements.
+ Out of hours responder for Separation Sciences equipment (fridges /freezers / incubators)
+ QC Representative for Separation Sciences at Amgen network meetings
+ Developing and coaching the QC Separation Sciences team.
+ Ensure timely completion of lab investigations and deviations through the relevant procedures.
+ Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to Separation Sciences.
+ Participate in regulatory agency inspections as required.
+ Manage and contribute to the achievements of department productivity and quality goals.
+ Conduct performance appraisal reviews for staff and identify training requirements for further development of colleagues.
**Primary knowledge, skills, competencies and relevant experience**
**Knowledge:**
Broad technical knowledge within Separation Sciences area and expanding knowledge of related disciplinary areas, specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage.
Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization.
Enhances own knowledge through understanding business trends and objectives.
Knowledge of industry and business principles.
Understands the core business process and purpose of the functional area in Amgen's commercialization process.
Developing own project management techniques.
**Problem Solving:**
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information. Creates new procedures and processes to drive desired results. Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.
**Autonomy:**
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role. Experience leading cross-functional teams is desirable.
Manages multiple assignments and processes.
Independently determines approach to project.
May be responsible for specific programs and/or projects Independently develops solutions that are thorough, practical, and consistent with functional objectives.
**Contribution:**
Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean Provides training and guidance to others Extends capabilities by working closely with senior staff/experts within and outside the internal organization
**Skills:**
Lead with initiatives to identify and drive improvements Communication skills (verbal and written) at all levels
Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Presentation skills.
Escalate issues professionally and in a timely basis and know when to escalate.
Decision Making skills - will be required to make decisions independently Teamwork, Coaching and motivating others. Negotiation and Influence skills, Planning and Organisation skills. Investigation skills. Demonstrated ability to interact with regulatory agencies. Experience working with interdepartmental and cross functional teams and influencing decisions.
**Relevant experience:**
Bachelor's degree in a Science related field is required. 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2 - 3 years of specific QC laboratory management experience is desirable. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Proven experience of leading teams.