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Quality Control Environmental Monitoring Associate

3 months ago

Exton, United States Beacon Hill Full time

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**