Sr. Associate I, QC Lab Support & Compliance
Sr. Associate I, QC Lab Support & Compliance
BIOGEN (DENMARK) NEW MANUFACTURINGApS
Hillerød, 1 stilling
On behalf of Biogen Site Hillerød, we are looking for a dynamic and strong team player – with proven experience from the Biotech or Pharmaceutical industry.
If you are interested in Quality Control and Compliance and would like to be part of a dynamic and competent team in Biogen – the world’s oldest independent biotech company – this could be your way in.
Biogen offers a dynamic working environment in an exciting and rapidly growing industry where multi-cultural teams from all over the world work collaboratively on products that change lives. We are growing quickly, have an exciting product pipeline and are seeking positive people with a strong drive.
THE CHALLENGE
Sr. Associate I, QC Lab Support & Compliance, reports to the Sr. Supervisor, QC Lab Support & Compliance – Job Summary/Principle Accountabilities:
JOB SUMMARY – As Sr. Associate I you will be responsible for cross department tasks for QC regarding general compliance and harmonization of document quality and flow within QC, where all documentation is in accordance with GMP. Responsible for providing technical support for trouble shooting of complex laboratory investigations and coordination of optimizing laboratory systems. Prepares and analyzes metrics for quality compliance within QC.
PRINCIPLE ACCOUNTABILITIES:
-Uses deep technical knowledge. Drives complex investigations and assesses laboratory exceptions and investigations
-Harmonization of relevant QC document quality and workflows. Provides project support within the QC area. Handles Events, deviations, CAPAs, LEs, RARs, PEs and GCCs in order to support the quality systems
-Writes and harmonize procedures, protocols and reports in collaboration with global QC
-Relevant QC oversight tasks
-Other tasks may be assigned from time to time (e.g. assisting with Inspections/audits)
SCOPE/ACCOUNTABILITIES
The Sr. Associate I will write and review QC documentation in myCims, assess events, deviations and laboratory exceptions, and perform laboratory investigations in TrackWise. The Sr. Associate I will report into the Sr. Supervisor for QC Lab Support and Compliance and have a close collaboration with the other local and global QC staff.
THE IDEAL CANDIDATE
-Solid GMP and quality systems knowledge - preferably gained from working within one of the following industry segments: Biotech, pharmaceutical or related
-Work experience from QC and/or QA
-Pragmatic and yet systematic and thorough approach to quality and compliance
-Ability to plan, prioritize and complete own work
-Minimum 5 years of experience – from a similar position
-Relevant educational background – MSc, BSc, Associate degree or similar
-Excellent written and oral communication skills in English
-Experience from working cross-functionally as well as working with people from different cultures
-Excellent IT skills: MS Office/Excel/ERP/myCims/TrackWise – as well as a natural flair for quickly learning new systems
PERSONAL SKILLS/KEY WORDS
-Thrive in an international environment, where things are constantly changing
-Can work independently, take initiative, ownership and pride in your work
-Work both analytically and proactively
-Good collaborations skills with stakeholders, including global QC and QA
-Are easy-going, flexible, a good team player and perform your work with an open mind and sense of humor
-Team player/Adaptable/Constructive/High energy level
APPLICATION
Please forward your application including CV, and other relevant documents to: steen@storbjergsearch.dk – REF: SR. ASSOCIATE I, QC LAB SUPPORT & COMPLIANCE. For further information please contact: STORBJERG Search & Selection/Steen Storbjerg Nielsen +45 2999 9689
About Biogen
Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, autoimmune diseases and hemophilia. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases.
Founded in 1978, Biogen is the world’s oldest independent biotechnology company. Our development pipeline is one of the strongest in the industry and patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. In the coming years, we’re working hard to bring new therapies to market for patients with serious neurodegenerative, non-malignant hematologic and autoimmune diseases.
With approximately 7,000 people worldwide, Biogen is truly a global organization. Biogen’s European production site in Hillerød has a pivotal role in the supply of medicine to patients across the globe. The site hosts a large scale facility for manufacturing biologics, an assembly, label and packaging facility, an engineering & facilities organization as well as quality control and quality assurance. Biogen (Denmark) Manufacturing ApS in Hillerød is an exciting workplace for more than 540 employees representing more than 18 different nationalities.
At Biogen, science and innovation do not stop in the research lab. Biogen’s capabilities for protein manufacturing are world class in quality and scale and the company is one of a few biotechnology companies with several dedicated biological bulk manufacturing facilities around the globe.
