Location: Exton,PA, USA
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**