TITLE: Senior Environmental Monitoring Associate
LOCATION: King of Prussia, PA
TYPE: Contract to hire
SCHEDULE: Mon-Fri Day Hours
Overview:
Biotech company is looking for an experienced Quality Control- Environmental Monitoring Associate to join their team!
Responsibilities:
- Conduct environmental monitoring in support of Manufacturing and Quality Control, in ISO certified cleanrooms
- Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
- Perform Growth Promotion testing, air sampling, surface monitoring and water testing
- Maintain housekeeping in the cleanrooms and laboratories
- Assist the Quality Control department in daily operations, as needed
- Author and revise QC SOPs, respond to Out of Specification results
- 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 product 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 and implemented
Requirements:
- Minimum Bachelor of Science degree in a scientific discipline with 4-7 years of environmental monitoring experience in an aseptic environment
- Knowledge of Current Good Manufacturing Practice and Industry standards
- Experience in a similar role in the biologics or pharmaceutical industry
- Excellent verbal, written and organizational skills
- Must be open to occasional off shift and weekend work
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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