Job Description

_ General Responsibilities:_
Performs environmental monitoring in support of aseptic product manufacturing, media fill batches, and personnel monitoring. Performs raw material release testing in support of aseptic product manufacturing.

Responsibilities:

• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing, and particulate monitoring inside the clean rooms.
• Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed.
• Perform Growth Promotion testing on prepared media.
• Perform environmental monitoring during aseptic process media fills batches.
• Maintain housekeeping in the Quality Control laboratories.
• Assist the Quality Control department in daily operations, as needed.
• Revise QC SOPs as necessary to maintain compliance.
• Respond timely to Out of Specification (OOS) results, including notification to area management.
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
• Training of other employees as necessary.
• Participation in investigations to ensure that potential problems and root causes are identified, impact assessed, and actions to prevent recurrence are considered and implemented.

Qualifications

** Basic Minimum Qualifications:**

• BS degree in a scientific discipline
• 2+ years of experience in a similar role in the biologics or pharmaceutical industry
• Knowledge of Current Good Manufacturing Practices (cGMPs) and Industry Standards
• Experience in aseptic processing and mammalian cell culture
• Familiarity of basic laboratory equipment such as microscopes, pH meters, incubators, etc.
• Ability to demonstrate proficiency in Microsoft products (Word, Excel, PowerPoint)
• Excellent verbal, written, and organizational skills
• Good interpersonal and communication skills
• Must be open to occasional off shift and weekend work

Additional Information

Position is Full Time, Monday-Friday, 8am-5pm. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

** What we offer:**

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.