General Responsibilities:

Performs environmental monitoring in support of aseptic product manufacturing.

Responsibilities:

·         Perform viable and nonviable environmental monitoring and support of Manufacturing and Quality Control in the form of air testing, surface testing, personal testing, and particulate monitoring.

·         Perform batch record verification of critical processing steps performed by Manufacturing during a septic product manufacturer, ensuring accuracy of steps performed.

·         Perform Growth Promotion testing on prepared media.

·         Direct Sterile Media Trials and perform support testing.

·         Maintain housekeeping in the Quality Control laboratories.

·         Assist the Quality Control department in daily operations, as needed.

·         Author and revise QC SOPs as necessary to maintain compliance.

·         Timely response to Out Of Specification (OOS) results, including notification to area supervision.

·         Communicate with the individual operations departments (Manufacturing, Quality Assurance, Facilities) to ensure that company objectives are met on schedule.

·         Employment of myriad analytical equipment in support of prior quality.

·         Training of other employees as necessary.

·         Completion of thorough Manufacturing Investigation Reports (MIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered an implemented.

Computer Skills:

·         To perform this job successfully, and individuals should have knowledge of Database software; Project Management software; Spreadsheet Software, and Word Processing software.

Education:

·         Minimum Bachelor of Science degree in a scientific discipline.

Experience:

·         Viable Air Sampling, Non-Viable Air sampling, USP water testing, surface monitoring, Gram Stain Identification

·         Aseptic gowning training (Class B, ISO 5, ISO 7)

·         Knowledge of Current Good Manufacturing Practice and Industry standards

·         Experience in a similar role in the biologics or pharmaceutical industry

·         Experience in aseptic processing and mammalian cell culture production.

·         Familiarity of basic laboratory equipment such as microscopes, pH meters and incubators.

·         Excellent verbal, written and organizational skills.

·         Good intrapersonal and communication skills.

·         Must be open to occasional off shift and weekend work.

**Compensation is flexible based on background and level of experience**