Stability & Operations Analyst - East Rutherford

Cambrex

Stability & Operations Analyst

BE--

Cambrex - Belgium

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

• 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

Apply Here

Apply Here: https://www.click2apply.net/RWJkxWhWJXME8F8PMcOVdX

PI249724034