Serán BioScience is searching for an experienced Analyst to help develop and maintain a Microbiology Testing Program 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. While all levels of experience are encouraged to apply preference will be given to candidates with experience in bioburden method development and method verification/validation.
\n Duties and Responsibilities Conducts microbiological testing to support test method verification, product/raw material release, hold time studies, and equipment cleaning studies Performs routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environmentsPerforms 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 protocolsPerforms growth promotion testing and qualifications to support environmental monitoring strategyPerforms swab sampling of manufacturing equipment to support cleaning process verification testingTrends environmental monitoring data and writes environmental monitoring trend reports· Initiates and supports deviation and laboratory investigationsTrains peers to perform EM testing Maintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activitiesCoordinates with members of other departments to schedule sampling events and ensures timely communication of test resultsAdheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policiesIdentifies opportunities for improvement and takes initiative to lead improvement effortsAdjusts work schedule when necessary to meet testing needsResponsibilities may increase in scope to align with company initiativesPerforms other related duties as assigned Required Skills and Abilities Strong verbal and written communication skillsDemonstrated ability to collaborate and work in cross-functional teamsExcellent organizational skills and attention to detailStrong time management skills with a proven ability to meet deadlinesAbility to prioritize tasks and to facilitate delegation of tasks when appropriateAbility to function well in a high-paced and dynamic environmentProficient with Microsoft Office Suite or related software Education and Experience Bachelor's degree in scientific discipline, with degree in microbiology preferredRequires a minimum of 3 years GMP experience with 3-5 years performing environmental monitoring testing and/or microbiological testing (title commensurate upon experience)Experience in aseptic manufacturing and/or oral solid dosage form manufacturing preferred Physical Requirements Prolonged periods of sitting or standing in laboratory and manufacturing environmentsMust be able to lift up to 15 pounds at times
\nCompensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing and pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701