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
