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. Job Overview Through our support of international pharmaceutical and medical device companies, Q1 Scientific (a part of Cambrex) plays a critical operational role in the production chain of healthcare products. Our purpose‑built facilities in Waterford and Belgium offer state‑of‑the‑art sample storage, ranging from ultra‑low freezers at –80°C to storage over 50°C. This Operations Technician position in Waterford provides an opportunity to build experience across operations and quality. You will report to the Stability Lead while performing sample management activities. Responsibilities Operations Receive and check customer deliveries to Q1 Scientific, highlighting any anomalies and ensuring secure, correct and timely storage of such deliveries in line with customer requirements, regulatory and quality guidelines. Take responsibility for retrieval, packing and delivery of samples back to customers. Ensure the facility is kept clean and equipment and maintenance schedules are maintained as specified by the Quality Management System (QMS). Demonstrate excellent organisational skills, openness to feedback and punctuality and trustworthiness at all times. Take on additional responsibilities and perform secondary operations and tasks as requested by the Team Lead to support the team during extra busy periods. Perform daily checks on stability cabinets/room conditions. Communicate effectively at all levels of the business, particularly regarding safety regulations. Provide general admin support and any other duties as may be required. Quality Ensure that all activities meet the quality standards specified by the Q1 Scientific QMS and in accordance with cGMP standards. Review completed documents for compliance to specification and ensure all entries are complete. Produce and manage quality reports around deviations. Support company safety and quality programmes, ensuring ongoing compliance with all regulatory requirements. Qualifications / Skills Excellent communication skills and proficiency in English language. Strong attention to detail, ability to work on own initiative and highly motivated. Conscientious and thorough approach to assigned tasks. Team‑oriented with outstanding collaboration skills, and ability to work to deadlines in a fast‑paced environment. Ability to work to strict deadlines, be a team player with well‑developed problem‑solving abilities. Highly numerate, computer literate with Microsoft Word and Excel skills to produce graphs and reports. A strong work ethic, highly flexible and willing to work as part of a team or on own initiative. A positive attitude to work and willingness to take ownership of projects, client relationships and timely responses and reporting. Education, Experience & Licensing Requirements 2+ years’ work experience in a temperature‑controlled storage environment (retail or warehouse), regulated manufacturing or pharmacy environment. Strong ability to motivate oneself, be results‑driven and performance‑focused. Experience working to standard operating procedures in a regulated environment (desirable but not essential). Previous experience in picking and packing materials. Experience using an inventory management system. Ability to complete quality documentation/reports. Experience using electric pallet trucks/forklifts an advantage but not essential. 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, fingers or arms; to reach; to handle or feel objects; to stand, walk, sit; occasionally climb or balance; regularly lift or move up to 10 pounds; frequently lift or move up to 25 pounds and occasionally lift or move up to 50 pounds. Specific vision abilities required include close, distance 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, respirators, 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. #J-18808-Ljbffr
Job Overview We are seeking applicants for the position of Quality Lead 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. Key Responsibilities Provide expert guidance and support to the Company on all Quality Management System (QMS) activities. Ensure all company operations comply with internal QMS requirements and applicable cGMP, GxP, and ISO standards. Maintain, monitor, and continuously improve the QMS by identifying risks, proposing enhancements, and driving corrective and preventive actions (CAPAs). Oversee the administration and maintenance of quality manuals, procedures, and records, and lead continuous improvement initiatives in collaboration with management. Ensure all planned and unplanned changes, deviations, and non-conformances are appropriately investigated, documented, and closed in line with regulatory expectations. Plan, conduct, and report internal audits to ensure ongoing compliance with GxP and ISO certification requirements. Serve as the Quality Lead for all internal, regulatory, supplier, and customer audits, including audit preparation, hosting, follow-up, and closure of audit findings. Quality Documentation & Administration Responsibilities Manage controlled documentation within the QMS, including the issuance, revision, and archiving of quality documents such as logbooks, protocols, and forms. Maintain document control systems and indexes (electronic and hard copy), including document numbering and version control. Review completed quality documents to ensure accuracy, completeness, and compliance with approved specifications and procedures. Propose, review, and implement document changes as required to support operational and regulatory needs. Verify second-person reviews and sign-offs for operational documentation where required. Provide Quality oversight support for operational activities. Perform daily checks of stability cabinets and controlled room conditions when required. Support sample receipt, inspection, and dispatch activities as appropriate. Deliver general quality and administrative support as needed. Qualifications and Skills Hands on experience with core Quality system activities such as Deviations, Investigations, Document Management and Audits. Understanding of regulatory inspection readiness and data integrity principles (ALCOA+). A proactive self‑starter with strong organisational skills, capable of independently managing priorities and delivering high‑quality work to deadlines. Excellent communication skills, with the ability to present complex information clearly and confidently to both team members and management. A collaborative, team‑focused mindset, committed to building strong working relationships and performing effectively in a fast‑paced environment. Hours of Work This is a full time, permanent position. Hours are 8:30 am to 5:00 pm, Monday – Friday. Education, Experience & Licensing Requirements Level 7 or 8 qualification in a relevant discipline such as Quality, Science, Chemistry, Biotechnology or related field. Equivalent combination of education and experience may be considered. Minimum of 5+ years’ experience working in a GxP regulated environment, including experience leading Quality activities, projects or junior team members. 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. #J-18808-Ljbffr
