Quality assurance specialist (QA support)
Lithuania - Vilnius Update time: July 29,2020
Job Description
Quality assurance specialist (QA support) works with GSD qPCR products quality questions. Employee is responsible and involved in various activities:
- •Participates in products deviations and complaints investigations
- •Participates in risks evaluations, change control and validation processes
- •Performs Gemba Walks in order to assure quality of processes and conformity to ISO standards
- •Participates in values stream projects (PPI projects, Kaizens, Just-do-it, technology transfers and NPIs)
- •Participates in Custom PCP projects
- •Support manufacturing department in preparation and during customer audits
- •Reviews manufacturing documentation than needed
- •Support manufacturing department in other activities, increase the maturity of Vilnius Quality system and assure conformity to ISO requirements
Minimum Education/Experience Requirements:
- Demonstrated experience processes for RUO, IVD or Medical device industries.
- Demonstrated ability to manage & implement various tasks within the function.
- Requires the ability to perform independently & as part of a team.
- Must be able to influence & negotiate with people & resolve issues.
- Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation.
- Ability to identify customer needs, issues and develop realistic solutions to meet needs & solve problems.
- Ability to communicate recommendation and decisions across a wide spectrum of the organization.
- Bachelor’s degree (or higher) in a Chemistry, Biotechnology, Biochemistry or similar field.
- Knowledge of Quality Systems, IVD/medical device/Pharma manufacturing and regulatory requirements over a number of years.
- Excellent communication and presentation skills.
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