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Scientist I, Quality Control
Key job activities:
• Collaborate with groups responsible for CMC program schedules (QC testing, importation of the product and regulatory activities requiring in-country testing) to establish/maintain inventory models that allow proactive inventory planning both for internal and external needs.
• Work with Sample Control and Qualifications group to maintain robust reference standard and assay control inventories that meet internal and external testing requirements.
• Work with Regulatory representatives in order to understand product and country specific requirements for impending material requests while preparing Quality groups to accommodate the requests.
• Work with Quality groups to establish best product specific testing practices (including test selection and testing practice) to ensure external laboratories are able to obtain required product quality information with minimum testing and consumption of inventories.
• Identify and implement strategies for process improvement opportunities.
• Plan, implement and direct operational aspects of Quality Control with respect to GMPs. Where necessary, track and trends key indicators of QC metrics for external testing requests.
Demonstrate initiative, creative thinking and reasoning and analytical skills
Work independently and with little supervision. Prioritize projects to meet deadlines as well as handling multiple projects simultaneously.
Operate effectively in a team setting as a leader, facilitator and team member.
Exhibit strong organizational and time management skills coupled with the ability to communicate effectively, both written and orally with vendors and internal personnel.
Demonstrate knowledge of cGMPs and equivalent regulations.
Proficiency with LIMS, Oracle, Trackwise, SharePoint, MS Project.
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