The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán BioScience. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordance with US-FDA, EU and other applicable regulations. Preference will be given to those with regulatory knowledge and experience in a pharmaceutical manufacturing environment. Those with a background in microbiology and environmental monitoring in an adjacent industry are encouraged to apply.
Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.
Duties and Responsibilities
Conducts routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environmentsConducts 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) Conducts growth promotion testing and qualification testing to support environmental monitoring strategyCollects equipment swab samples in the manufacturing environment to support cleaning process verification testingTrends environmental monitoring data and writes environmental monitoring trend reportsWrites microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activitiesAuthors Incident Reports, laboratory investigations, Change Controls, and CAPAs May represent EM/Micro as an SME in support of cross-functional initiatives 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 resultsLogs samples and standards into the QC LaboratoryAdheres 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 needsPerforms other related duties as assignedResponsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
Strong verbal and written communication skills Strong analytical and problem-solving skillsDemonstrated 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 Accepts feedback from a variety of sources and constructively manages conflictProficient with Microsoft Office Suite or related software
Education and Experience
Bachelor’s degree in scientific discipline. Degree in microbiology preferred. Scientist I requires 1 year performing environmental monitoring testing and/or microbiological testing in a manufacturing environment. Scientist II requires 2 years of GMP experience, 3-5 years preferred performing environmental monitoring testing and/or microbiological testing.
Physical Requirements
Prolonged periods of sitting or standing while monitoring equipment, analyzing data, or working on a computer Must be able to lift up to 25 pounds regularlyMust be able to wear a Tyvek suit with PAPR for extended periods of timeExposure to constant low-level equipment noise, and occasional high-level alarmsWork near heat generating equipmentMove up and down ladders, kneel, squat, balance on one foot Adheres to consistent and predictable in-person attendance
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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, along with access to pet insurance.
