Quality Control Analyst, Environmental Monitoring

Bend, Oregon /
Quality – Quality Control /
Full-time Exempt
/ On-site
Serán BioScience is searching for an experienced Analyst to help develop and maintain Environmental Monitoring within the Quality Control Department. This position will play a key role assisting manufacturing operations through performing environmental monitoring testing, utility testing, and supporting cleaning process verification testing. Ideal candidates will have a strong background in microbiology with several years of GMP experience. Those with environmental monitoring testing or microbiology testing are encouraged to apply.

Duties and Responsibilities

    • Performs routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environments
    • Performs quality control testing of utilities including high purity water systems (TOC, Conductivity, Endotoxin, and Bioburden) and compressed gas systems (hydrocarbon, moisture, bioburden, non-viable particulates, et cetera)
    • Supports environmental monitoring performance qualifications and execution of baseline testing protocols
    • Performs growth promotion testing and qualifications to support environmental monitoring strategy
    • Performs swab sampling of manufacturing equipment to support cleaning process verification testing
    • Trends environmental monitoring data and writes environmental monitoring trend reports·       
    • Initiates and supports deviation and laboratory investigations
    • Trains peers to perform EM testing
    • Maintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities
    • Coordinates with members of other departments to schedule sampling events and ensures timely communication of test results
    • Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
    • Identifies opportunities for improvement and takes initiative to lead improvement efforts
    • Adjusts work schedule when necessary to meet testing needs
    • Responsibilities may increase in scope to align with company initiatives
    • Performs other related duties as assigned

Required Skills and Abilities

    • Strong verbal and written communication skills
    • Demonstrated ability to collaborate and work in cross-functional teams
    • Excellent organizational skills and attention to detail
    • Strong time management skills with a proven ability to meet deadlines
    • Ability to prioritize tasks and to facilitate delegation of tasks when appropriate
    • Ability to function well in a high-paced and dynamic environment
    • Proficient with Microsoft Office Suite or related software

Education and Experience

    • Bachelor’s degree in scientific discipline, with degree in microbiology preferred
    • Requires 3 to 5 years GMP experience performing environmental monitoring testing and/or microbiological testing
    • Preference will be given to those with experience in an aseptic manufacturing environment

Physical Requirements

    • Prolonged periods of sitting or standing in laboratory and manufacturing environments
    • Must be able to lift up to 15 pounds at times