Foundation Medicine GmbH in Penzberg, Germany is seeking a Senior Quality Assurance (QA) Specialist to support local and global QA activities. In this position, you are responsible for all aspects around documentation management, including the use of various electronic quality management systems. You support training management activities and maintain employee training files. You will also ensure compliance with ISO, In Vitro Diagnostic and other applicable standards and regulations. In addition, you will provide support and contribute to other QA activities as needed. Lastly, you will be part of a growing team from various functions in Penzberg, and regularly interact with functions in the headquarter in Cambridge, USA.
What the job is about
· You assume responsibility for the creation, administration, and management of quality-related documents, such as standard operating procedures, validation reports, equipment qualification documents, and employee training files.
· You provide guidance to colleagues across departments on good documentation practice and facilitate review and archiving of documents.
· Additionally, you work with management in compiling data and metrics for Management Reviews.
· Finally, you contribute to other QA activities as needed and support QA and operations teams on continual improvement opportunities.
· You hold a Bachelor’s degree in Life Sciences, Engineering, or a related scientific field.
· You have at least two years of experience in a QA function or equivalent in the diagnostic, medical device, pharmaceutical, or biotechnology industry.
· Working experience with electronic quality management systems is highly desirable.
· Ideally, you have worked a regulated environment and have good knowledge of ISO 15189, ISO 13485, IVD-D/IVD-R, and/or GCLP.
· You are detail oriented with excellent prioritization and organizational skills and have a passion for documentation management.
· You are fluent in German and English language.
Development opportunities and benefits
· You can expect a high degree of independence and a flexible working environment.
· We stand for sincere and trust-based interaction with each other.
· Your personal and professional development is very important to us.
· All the advantages of a familiar work environment while being embedded in a large, global company.
We are looking forward to your application!
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.
Internal applicants, please use your FMI email address.
The past twelve months have been beyond exceptional and nobody can deny the impacts the global corona pandemic had on our daily lives. However, there were many positives. Our working environment had to quickly adapt to the new situation and employers and employees just the same had to accommodate to the new circumstances. Continued or exclusive work from remote has become “the new normal” – and to everyone’s surprise, it is working just as well.
Learn more from Vera , VP, International Operations & Managing Director Foundation Medicine GmbH.
Foundation Medicines European subsidiary is located within the Roche Campus in Penzberg, Germany, just a couple of miles south of Munich. Roche Penzberg is one of Europe’s largest biotechnology centers, employing around 6,200 people from over 50 nations.
In addition to laboratory operations, the site functions as hub for internal collaborations and partnerships. The central location in Europe and within the Penzberg campus allow for a strong synergy between Foundation Medicine, various national and international partners and Roche.
The Foundation Medicine team in Penzberg consists of several groups, such as Laboratory Operations, Client Services & Accessioning, Computational Biology, Quality Assurance, Automation Engineering, Project management, Finance and IT. Many of the Roche amenities on campus can also be used by Foundation Medicine employees, such as the gym, canteen, and bus services.
Learn more about our German location from our Project Manager, Barbara.
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