Quality Control Analyst II/III

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