Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Quality
The Microbiologist III supports the testing in the Microbiology laboratory at the Xellia Cleveland site. In this role, the Microbiologist III is responsible for will be responsible for all aspects of the Microbiology laboratory operations, such as sample receipt, sample testing, data generation, data analysis and summarization and other QC lab supporting activities. Serves as a project leader and key technical contributor Uses good documentation practices in the collection of data/records. Authors and executes qualification documents, SOPs, protocols, and investigations. Recommends corrective actions or process improvements that will eliminate the potential for laboratory deviations.
Key Responsibilities
- Microbiological testing to include; bioburden, endotoxin, identification of microorganisms, particulate analysis, raw material sampling, and API analysis
- Serve as a subject matter expert for testing, validation and qualifcation
- Data review, analysis, and interpretation
- Instrument and method qualification/validation
- Document review
- Document all work performed according to applicable Current Good Documentation Practices
- Support laboratory investigations and deviations
- Responsible for training laboratory personnel
- Maintain the laboratory supply through regular inventory management
- Communicate inventory needs for test materials and supplies
- Performs project work and participate in investigations
- Technical writing to include protocol and method development
- Responsible for handling of waste and transfer to central point as defined by procedures
- Trains other QC members in QC methods and process
- Serves as an expert in a specific area of laboratory equipment, processes or systems
- Participation in continuous improvement initiatives to improve work practices in quality department
- Help ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards
- Perform additional tasks as needed
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination
- Perform additional tasks as needed
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Protective apparel, such as lab coat, head, face, hand, and arm coverings, shall be worn as necessary to promote safety and to protect drug products from contamination
Qualifications
- Bachelor’s degree in a scientific discipline (Microbiology, Biology, Biotechnology, Biochemistry, etc.) or equivalent. Advanced degree preferred
- 3 to 5 years of experience in a cGMP laboratory (pharmaceutical/medical device) environment
- Expereince with bioburden, endotoxin, identification of microorganisms testing is strongly preferred
- Leadership ability. Ability to coach and mentor peers
- Advanced understanding of cGMP and FDA requirements for laboratory operations
Physical Requirements of the Role
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is often sitting and typing. Frequently talking, standing, walking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 50 lbs. Bending over, and repetitive use of legs are done occasionally. Work regularly under desirable conditions of the office and laboratory setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn
Information og data
Denne ledige stilling har jobtypen "Biolog", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Biolog
- København
Lignende jobs
-
Instruktorater på Biologisk Institut (Bioinformati...
Biologisk institut søger instruktorer til Bioinformatikstudiecafé på bacheloruddannelsen ibioinformatik for studieåret 2024/2025.Med inspiration fra vores søsteruddannelser i Biologi, B..Få mere info- Biolog
- København
-
Molekylærbiologer til Afdeling for Patologi, Diagn...
[xxxxx]s Afdeling for Patologi søger molekylærbiologer til dynamisk team.Patologien er et fagområde i rivende udvikling med mange spændende problemstillinger og udfordringer, og geneti..Få mere info- Biolog
- København N
-
Data Privacy Analyst at the Neurobiology Research ...
A ~12 months position is available at the Neurobiology Research Unit (NRU) at [xxxxx] and University of Copenhagen (UCPH), Denmark, with a starting date based on receiving a suitable candi..Få mere info- Biolog
- København N
Statistik over udbudte jobs som biologer i København
Herunder ser du udviklingen i udbudte biolog i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal biologer i København.
Se flere statistikker her:
Statistik over udbudte biologer i København over tid
| Dato | Alle jobs som biologer |
|---|---|
| 14. november 2024 | 3 |
| 13. november 2024 | 3 |
| 12. november 2024 | 3 |
| 11. november 2024 | 4 |
| 10. november 2024 | 5 |
| 9. november 2024 | 5 |
| 8. november 2024 | 5 |
| 7. november 2024 | 5 |
| 6. november 2024 | 5 |
| 5. november 2024 | 5 |
| 4. november 2024 | 4 |
| 3. november 2024 | 5 |
| 2. november 2024 | 5 |
| 1. november 2024 | 7 |
| 31. oktober 2024 | 8 |
| 30. oktober 2024 | 8 |
| 29. oktober 2024 | 7 |
| 28. oktober 2024 | 8 |
| 27. oktober 2024 | 8 |
| 26. oktober 2024 | 8 |
| 25. oktober 2024 | 5 |
| 24. oktober 2024 | 7 |
| 23. oktober 2024 | 8 |
| 22. oktober 2024 | 8 |
| 21. oktober 2024 | 9 |
| 20. oktober 2024 | 11 |
| 19. oktober 2024 | 11 |
| 18. oktober 2024 | 12 |
| 17. oktober 2024 | 10 |
| 16. oktober 2024 | 11 |
| 15. oktober 2024 | 9 |
Værd at vide når du søger job som biolog i København
Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.
Bydele i København
København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:
Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.
Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.
Find ledige jobs i Valby
Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.
Mere information om København
Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer