Hilo by Aktiia
Sr. Quality Engineer - Product Development(m/w/x)
Vollzeitmit HomeofficeSenior
Neuenburg
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Managing stability study inventory and sample placement at specific conditions for pharmaceutical development. Bachelor's degree in a scientific discipline and cGMP understanding required. Work-life balance programs, employee resource groups.
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Anforderungen
- Bachelors degree in Chemistry, Microbiology, or related scientific discipline
- Experience with stability programs desired
- Solid understanding of cGMPs and regulatory principles
- Excellent verbal, written, and interpersonal communication skills
- Ability to work independently and in a team
- Proficient computer software application skills
- Accurate recordkeeping, thorough documentation, attention to detail, efficient organization/management of records and time
Aufgaben
- Manage stability study inventory, including sample receipt
- Place samples at appropriate conditions per approved protocols
- Manage timepoint pull schedules and sample pulls with testing labs
- Perform storage unit maintenance and inventory control
- Manage sample destruction, pulls, and deliveries
- Reconcile inventory
- Review stability data and trends
- Identify stability annual requirements from manufacturing site
- Support stability program activity execution for current and new products
- Engage with sample management program and logistics generation
- Engage with master stability protocol and stability study protocol generation
- Review stability study LIMS build for accuracy
- Identify, write, and revise applicable SOPs
- Write technical report sections for sample storage and management
- Write and revise annual stability requirement documents
- Escalate information regarding stability program management to management
- Provide team training needs for ongoing stability activities
- Ensure training requirements are met
- Work according to cGMP requirements and HA expectations
- Interact with inspectors during facility tours
- Support stability storage chamber maintenance with contractors and personnel
- Enter work orders in designated systems for chamber maintenance
- Maintain and review environmental charts and log sheets
- Respond to chamber-related events
- Enter test results from contract laboratories into study management systems
- Provide administrative support for department training, financial, filing, and archiving
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Competitive benefits
- Employee resource groups
- Reasonable workplace accommodations
Flexibles Arbeiten
- Work-life balance programs
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Bristol Myers SquibbÜber das Unternehmen
BR
PharmaceuticalsBoudry
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
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