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Quality Management Representative (w/m/d)

biotechrabbit is a young, dynamic biotechnology company in Berlin with a range of high-quality laboratory reagents for the molecular diagnostics industry and life science research. Key focus is the development and production of proteins and optimized reagents. Founded in 2011, we have built a global customer and trading partner network within a short period of time. Innovative products, quality, reliability and excellent support are convincing our worldwide customers and are the key to constant growth.

To strengthen our team, we are looking for a Quality Management Representative (w/m/d)

Duties & responsibilities:

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
  • Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
  • Coordinates legal requests in support of government investigations or litigations
  • Ensures the quality assurance programs and policies are maintained and modified regularly
  • Facilitates uniform standards for the site and enables best practice sharing, thereby fostering the achievement of company's mission globally
  • Management and facilitation of quality documentation system
  • Work within an ISO regulated manufacturing area to provide and assist in the implementation of quality-related continuous improvement opportunities
  • Promote and derive internal processes, procedures, and best practices
  • Training employees on good documentation skills
  • Recording and filing all ISO relevant documents in the system

Job requirements:

  • Minimum Bachelor's degree in a science or technical related field and 3+ years of work experience in Quality or regulated industry
  • Experience with QMS and validated software
  • Document control system operations
  • Experience in ISO 13485 and ISO 9001 Quality Management and Auditing Fundamental
  • Strong attention to detail and diligent approach
  • Ability to establish and maintain effective work relationships
  • Demonstrated in skills in MS Office with software knowledge to utilize a database and produce requisite reports.
  • Knowledge and experience in operating ERP systems
  • Demonstrated ability to manage multiple activities and priorities in a dynamic, fast-paced, client-focused environment
  • Some knowledge of accounting, procurement and/or contract management would be a plus
  • Excellent oral and written language skills in both German and English

 

We offer an interesting and versatile position at our location in Berlin-Adlershof with an international partner and customer base.

You are part of a dynamic and flexible team that is working with great enthusiasm to steadily improve the company's offer and contribute to its continued success.

Please send your application to hr@biotechrabbit.com stating the possible date of entry and your salary expectations.

 

biotechrabbit GmbH Personalabteilung
Volmerstraße 9
12489 Berlin

hr@biotechrabbit.com