Sterility Quality Assurance Analyst

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Job Description

This position is located in our Round Lake, IL Facility.

This position will facilitate and manage the oversight of routine and investigational samples, own and provide support for CAPA investigations, review, approve and maintain trending of third-party laboratory results, and support the facility's Contamination Control Program.

Responsibilities:

• Provides timely reporting of third-party Microbiology Lab KPIs; trends and analyzes microbiological testing and EM data to support Management Review.
• Own and support investigations related to environmental and utility monitoring out of limits deviations.
• Provide support to external departments for completion of investigations.
• Acquire and maintain cleanroom and gowning qualification for cleanroom manufacturing areas.
• Provide support to the facility's Contamination Control Program and continuous improvement initiatives.
• Basic understanding of microbiological techniques and concepts. • Conduct investigational sampling in support of investigations.
• Support logistics and oversight of routine and investigational samples with our third-party Microbiology and Chemistry laboratories.

Qualifications / Experience:

• Strong background in Microbiology.
• Strong analytical and problem solving skills.
• Excellent verbal and written communication skills in English
• Must be able to deal with ambiguity and make decisions under stressful conditions
• Should be current in knowledge of state-of-the art processes and systems related to production as well as contamination control and aseptic practices in cleanrooms.
• Must be able to work in controlled/classified environments requiring special gowning. Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. • Deals with plasma-derived finished products; transfer of intermediates and products between sites/countries.
• A degree in Microbiology or other science with a minimum of 1 to 3 years of experience in Quality, Aseptic Manufacturing (preferably with strong focus on fill/finish operations) or related field in the pharmaceutical industry. Non-degree with adequate work experience will be considered. • Work as a team member in meeting departmental goals and objectives

Cannot be allergic to Cephalosporin drugs to apply for this position.

Location and Salary Information: This job posting excludes CO applicants.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time