Company

As a clinical-stage pharmaceutical company, Revalesio aims to restore hope through a fundamentally new approach to treating neurodegenerative diseases. Over the last 18 years, we have been determined to develop a new class of therapeutics to treat debilitating diseases and improve quality of life. Revalesio’s team is made up of passionate individuals who are inspired to innovate. We partner with internationally renowned scientists and professionals in biomedical research, helping to create our unique and dynamic work environment where everyone is encouraged to share their perspective and provide valuable contributions.

Location: Tacoma, WA

Job Summary

The QC Microbiologist is responsible for quantitative and qualitative analysis of pharmaceutical manufacturing environments according to FDA, ISO, cGMP, and Revalesio Standard Operating Procedures. These areas include: cleanroom, warehouse, drug product, drug substance, and FIYO sampling. The Microbiologist will also be responsible for maintaining, updating, and trending current procedures and data in accordance with local and international standards to support manufacturing, distribution, and clinical trials. As part of the Quality Control department the microbiologist will also assist where needed during routine drug manufacture, inspection, and release.

Key Responsibilities

• Environmental monitoring of cleanroom areas including surfaces, air, water, and personnel
• Routing testing in support of drug manufacturing and development
• Protocol and report generation / review for equipment validations / qualifications, and analytical method validations, which support QC activities
• Ordering / stocking of QC supplies
• Preparation of medias and reagents
• Compilation of Quality Control data for trending and evaluation
• Maintenance and update of Quality Control programs (e.g., environmental monitoring, microbiome library) to meet or exceed regulatory requirements
• Revision and creation of GMP documents as needed
• Adherence and participation in Quality Systems (e.g., CAPA, laboratory investigations, root cause analysis, etc.)
• Training of junior staff within the QC department
• Other responsibilities as assigned or needed

Minimum Qualifications

• Minimum of a Bachelor’s Degree preferred (B.S.) in Microbiology, Biochemistry, or closely related field with 3+ years prior laboratory experience, other degrees may be considered depending on work / education combinations
• Vision corrected to 20/20 vision
• Lift minimum of 50 lbs

Experience Requirements

• Minimum of 3+ years in a regulated GMP environment. Other regulated environments considered depending on experience (GxP)
• Previous validation experience with scientific equipment, analytical tests, and computer / equipment interfaces
• Familiarity with Electronic Documentation Systems (ERPs, ELN, or similar) preferred
• Familiarity with data trending for the use of alarm and alert levels or out of trend (OOT) analysis

Skills and Knowledge

• Proven work record of timely and efficient project completion
• Thorough knowledge and execution of Equipment, Process, and Analytical Validations
• Advanced knowledge of microbiological test methods, including isolation, identification, sequencing, storage, and propagation
• Thorough understanding of the creation and revision of GxP documents including but not limited to SOPs, Protocols, Analytical Methods, and Reports
• Working knowledge, interpretation, and implementation of regulatory standards (e.g., ISO, FDA, EMA, etc.)

Interpersonal Skills

• Excellent verbal and written communications
• Self motivated team player and can do attitude
• Supervisory experience a plus

Salary

$55,000 to $75,000

Benefits

We offer a wide range of benefits, including:
• 401(k) with company match
• Medical, dental, and vision insurance
• Paid vacation and holidays

Revalesio Management Inc. is an Equal Opportunity Employer

Please apply at careers@revalesio.com