Quality Control Analyst Ii/iii (micro/environmental Monitoring)

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. While all levels of experience are encouraged to apply preference will be given to candidates with environmental monitoring or microbiology testing.

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 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 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 environments
• Must be able to lift up to 15 pounds at times