Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

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

The Stability and Operations Analyst is responsible to receive the samples and to participate to the stability storage management, together with the management of the facility and its equipment.

Responsibilities

Administration of quality and operations documents, continuous improvement initiatives and interaction with management personnel on quality and operations topics to include but not limited to:

• Check samples on receipt at Q1 Scientific/on return to Client as appropriate.
• Organise the collection and delivery of products to/from customers
• Complete all study documents in accordance with the quality management system
• Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.)
• Maintenance of indexes (electronic and hard copy)
• Review of completed documents for compliance to specification and to ensure all entries are complete
• Proposing/reviewing document changes as appropriate
• Checking off second signature for Operations as appropriate
• Performing daily checks on stability cabinets/room conditions as appropriate
• Providing general admin support as required
• Be available in case of urgent interventions at the facility out of normal working hours (clients studies, thermal cycling, …

Facilities Management :

• Provision of assistance for the cleanliness of the facility and compliance with equipment and maintenance schedules, in line with the quality management system
• Be available in case of urgent interventions at the facility out of normal working hours (repairs, breakdowns, …)
• Assist in the development, optimisation and validation of new equipment.
• Order consumables and maintain sufficient quantities of spare parts, office supplies and sundries
• Contribute to extension projects of the facilities

General Office Administration :

• Answering telephone calls and emails and dealing with problems in a timely manner
• Maintain administrative records, including invoices, delivery notes and contractor reports
• Liaise with external consultants and contractors

QMS:

• Provision of assistance and advice to the Company on all QMS activities (writing, investigation, training,…)
• Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP and GDP standards
• Performing investigation for all CAPA following planned and unplanned deviations, quality events

Audits:

• Provision of assistance to all internal, regulatory, supplier and customer audits

Customer Care/Business Development :

• Business development: attach great importance to customer satisfaction
• Develop and implement effective plans to achieve the company's objectives
• Continuous review/improvement of operations and systems

Backup role :

• Act as backup of the Operations Lead

Qualifications/Skills

Stability and Operations Analyst is responsible to receive the samples and to participate to the stability storage management, together with the management of the facility and its equipment.

Education, Experience & Licensing Requirements

• Primary degree in science or logistics or business administration
• Experience in working in a regulated environment
• 5-8 years’ experience in logistics or life sciences industry
• French and English fluency