Quality Control Environmental Monitoring Associate

4 weeks ago

Exton, United States Beacon Hill Full time

*Hours must be flexible to support manufacturing (weekends, off-hours, holidays) on occasion.

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:

Knowledge of Current Good Manufacturing Practice and Industry standards

Experience in a similar role in the biologic 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 interpersonal and communication skills.

Must be open to occasional off shift and weekend work.

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