Posted 3d ago

Quality Technician

@ Cambrex
Waterford, Waterford, Ireland
OnsiteFull Time
Responsibilities:Maintain QMS, Review documents, Coordinate audits
Requirements Summary:Degree in science (desirable); regulated environment experience; 1–2 years in quality/administrative roles; strong attention to detail and organizational skills; full-time permanent role; 8:30am–5pm, Mon–Fri.
Technical Tools Mentioned:QMS, eQMS, CAPA, document control
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Job Description
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview We are seeking applicants for the position of Quality Technician to join our team. This role will report directly to the Quality Manager for Waterford and will be a pivotal role in our growing Quality department. Responsibilities Quality Management System (QMS) Provision of assistance and advice to the Company on all QMS activities. Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards. Continually monitors the QMS system suggesting improvements and CAPA measures. Ensure all planned and unplanned changes (deviations) are adequately investigated and documented. Review of completed documents for compliance to specification and to ensure all entries are complete. Proposing/reviewing document changes as appropriate Maintenance of indexes (electronic and hard copy) Issue of document numbers and controlled documents (logbooks, protocols for execution etc.) Providing admin assistance to the Company on all eQMS activities Working in collaboration with team members Audits: Ensure compliance to GMP certification by conducting and reporting internal reviews. Co-ordinates and prepares for all internal, regulatory, supplier and customer audits. Qualifications/Skills Strong attention to detail and organisational skills Education, Experience & Licensing Requirements A degree in a science-related discipline (desirable) Experience working in a regulated environment (advantageous) 1–2 years’ experience in a quality or administrative role (preferred) Strong attention to detail and organisational skills Hours of Work This is a full time, permanent position Hours are 8.30am to 5pm, Monday – Friday Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.