Medical Device Regulatory jobs

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

Through our support of international pharmaceutical and medical device companies, we very much see Q1 Scientific as being part of a customer’s own operational and production chain. The healthcare products provided by these companies are vital and we are privileged to perform our part in the provision of those products to the global market.

Our purpose-built facilities in Waterford and Belgium, offer walk-in rooms and reach-in cabinets for sample storage at specific temperature and humidity conditions ranging from ultra-low freezers at -80°C to storage over 50°C.

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.

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.

Education, Experience, and 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

This is a full-time, permanent position

• Hours are 8.30 am to 5 pm Monday – Friday, with some requirement to work outside of these hours.

Travel:0%

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment and Protective Equipment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with country Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

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.

Pay: €38,000.00-€43,000.00 per year

Location:

• Waterford, County Waterford (preferred)

Work Location: In person