Senior Scientist for QC Microbiology - Redmond, WA
Join to apply for the Senior Scientist for QC Microbiology - Redmond, WA role at Evotec
Senior Scientist for QC Microbiology - Redmond, WA
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Job Title: Senior Scientist for QC Microbiology
Location: Redmond, WA site based.
Just-Evotec Biologics is seeking a skilled Senior Scientist for QC Microbiology experience to join our dynamic team. This role provides the QC analysis of raw materials, in-process, drug substance samples in support of our GMP manufacturing operations at our GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.
This role is site based with the main location in the Redmond, WA, US.
Responsibilities
- Perform QC Microbiology routine/non-routine GMP operations including:
- Environmental Monitoring (sampling and plate reading).
- Water sampling and testing (e.g., Bioburden, Endotoxin, Total Organic Carbon).
- Product testing (e.g., Bioburden and Endotoxin).
- Microbial identification.
- Growth promotion.
- Perform microbiological method validation/verification for new products.
- Assure timely and accurate completion of GMP documentation.
- Support QC management in the timely review of data.
- Support the Contamination Control team by providing Environmental and Utility monitoring data.
- Conduct laboratory investigations, deviations, OOS, change controls and CAPAs
- Support equipment qualification (IQ, OQ, PQ).
- Create, maintain, and revise SOPs, methods and associated documents.
- Support all operations of the QC labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
- Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters.
- Participate in daily and weekly operation meetings.
- Provide on-the-floor mentorship, training and technical leadership for less experienced staff as an individual contributor.
- BS in Microbiology, Biology or related field and min. 5 years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
- Extensive laboratory experience with environmental monitoring and water sampling and testing (bioburden, endotoxin, TOC and conductivity).
- Experience with microbial identification.
- Knowledge of GMP, USP, ICH, and other regulatory requirements and experience with regulatory compliance inspections.
- Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time.
- Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint).
- Ability to work independently and with others to accomplish goals and priorities.
- Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information Technology
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#J-18808-LjbffrSenior Scientist for QC Microbiology - Redmond, WA in redmond at Unknown Company
This position is listed as full time and onsite.