Quality Assurance Manager
Quality Assurance Manager
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1 Vacancy
Job Description
We are looking for a QA Manager to join the BioLamina Quality Department. In this role you will be responsible for establishing internal quality procedures standards specifications and systems. You will oversee the administration and continuous development of our Quality Management System (QMS) while supporting other departments to ensure that BioLaminas operations meet all defined quality requirements.
At BioLamina our quality management system adheres to the ISO 9001:2015 standard with a commitment to continuously enhancing our standards for the future. If you have a strong focus on quality assurance continuous improvement and thrive in a collaborative environment we would love to hear from you!
Key Responsibilities
- Release of LN and CAP
- Handling deviations Change Controls (CC) and CAPA related to product release.
- Conduct quality assurance review and approval of key documentation including but not limited to deviations change controls CAPA studies specifications and statements.
- Provide quality training and guidance to personnel.
- Prepare for and participate in annual ISO 9001:2015 audits coordinate other audits.
- Serve as the QA representative in crossfunctional projects.
- Foster a strong quality culture within the company by developing and maintaining effective collaboration with all departments.
- Ensure compliance with the BioLamina Quality Management System (QMS) while actively contributing to its continuous improvement.
Qualifications & Requirements
Prior experience as a QA Manager is not required; however the ideal candidate should have the following qualifications:
- A bachelors or masters degree in a relevant field.
- At least two years of experience working in a regulated environment with expertise in protein manufacturing cell processing and analysis.
- Handson experience with deviation investigations.
- Proficiency in writing change controls (CC) and CAPA.
- Proficiency in both written and spoken English.
- Prior experience in the biotech industry is a plus.
BioLamina
At BioLamina you will be part of an international valuedriven organization working alongside dedicated and highperforming colleagues. We believe our products can change the world and we have high ambitions to do so. BioLamina is a learning organization and we do this from each other and from the outside. We value our employees and we are committed to ensuring that the work environment is pleasant sustainable and safe.
We pride ourselves in providing an equal workspace making sure people are given equal opportunities equal pay and are well accepted for their differences. Furthermore we embrace diversity and inclusion in all aspects of our business.
BioLamina AB is a Swedish biotech company founded on scientific innovations at Karolinska Institutet. Our main products are recombinant laminins human proteins used to maintain and expand pluripotent stem cells and other primary cell types for subsequent differentiation into specialized cell types. BioLamina is revolutionizing cell culture and our products are used by researchers worldwide to develop cellular therapies and contribute to the era of regenerative medicine. For further information please visit:
Employment Type
Full Time
