Quality Control Scientist I​/II, Environmental Monitoring​/Microbiology

The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán Bio Science. 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 Bio Science 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.

• Conductsroutineenvironmental monitoring sampling and testing includingviableair,viable surface, and non-viable particulatetestingin non-sterile and asepticprocessingenvironments
• Conducts 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 qualificationtestingto support environmental monitoring strategy
• Collectsequipmentswab samplesin the manufacturing environment to support cleaning process verification testing
• Trends environmental monitoring data and writes environmental monitoring trend reports
• Writes microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activities
• Authors Incident Reports, laboratory investigations, Change Controls, and CAPAs
• May represent
  
  EM/Micro as an SME in support of cross-functional initiatives

• Maintainslaboratorycleanlinessand organizationthroughroutine disinfection of laboratory surfaces and equipment,inventory management, and participation in 5S activities
• Coordinates with members of other departments to schedule sampling eventsandensurestimelycommunication oftestresults

• Logs samples and standards into the QC Laboratory
• Adheres to Standard Operating Procedures,cGMPs, Quality Manual, and company policies
• Identifiesopportunitiesforimprovementand takes initiative to lead improvement efforts
• Adjusts work schedule when necessary to meet testing needs
• Performs other related dutiesasassigned
• Responsibilities may increase in scope to align with company initiatives

• Strong verbal and written communication skills
• Strong analytical and problem-solving 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 tofacilitatedelegationof taskswhen appropriate
• Ability to function well in a high-pacedanddynamicenvironment
• Accepts feedback from a variety of sources and constructively manages conflict
• Proficient with Microsoft Office Suite or related software

• Bachelor’s degree in scientific discipline.
  
  Degree in microbiology preferred.
• Scientist I requires1 year performing environmental monitoringtestingand/or microbiological testingin a manufacturing environment.
• Scientist II requires2yearsof
  
  GMP experience, 3-5 years preferred performing environmental monitoringtestingand/or microbiological testing.

• Prolonged periods of sitting or standing whilemonitoringequipment, analyzing data, or working on a computer

• Must be able tolift upto 25 pounds regularly

• Must be able to wear a Tyvek suit with PAPR for extended periods of time
• Exposure to constant low-level equipment noise, and occasional high-level alarms
• Work near heat…