QC Scientist I

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

Environmental Monitoring Scientist will be tasked with the performance of tasks in support of the manufacture of Commercial and Clinical Biologics, following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to environmental monitoring to ensure an accurate depiction of control for multiple production areas. These functions may include but are not limited to activities such as viable microbial sampling, microbial surface sampling, non-viable (particle) sampling, collecting samples from the on-site water system and process gas system.

What we do?

We perform routine environmental monitoring of viable/non-viable air, contact surface, water, and gases in accordance with our site procedures. Activities are detailed to meet cGMP requirements and perform document reviews and revisions. We interpret data results using concepts of microbiology, industry standards, and site SOPs and policies.

We perform critical evaluation of processes, including foresight and thinking ahead, as well as complete preventative maintenance and work notifications tasks on time and perform equipment testing and routine troubleshooting.

Tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.

Participate in 1-1's, department meetings, and attend meetings as to facilitate area needs based on changes, etc.

This position requires regular onsite attendance in order to satisfactorily perform duties. Weekend work is limited, but required as a scheduled activity.

How will you get here?

No experience required, but 1-3 years of relevant lab experience in a related field or industry preferred.

Bachelor's degree in Biology or other applicable field.

Experience in cGMP environment preferred.

Experience with gLIMS, water testing and/or environmental monitoring in ISO classified areas seen as a plus.

Knowledge, Skills, Abilities

Knowledge.

We try to understand 'why' and not just the 'how' of processes and practices.

Knowledge of cGMP practices, aseptic techniques, or microbiological concepts seen as a plus

Knowledge of industry standards such as ISO, ICH, FDA and USP

Skills

• MS Office (Word, Excel, Power Point, etc.)
• Strong prioritization skills
• Detail oriented
• Effective time management

Abilities

• Able to read, write, and communicate in English
• Able to understand and carry out instructions
• Reliable
• Effective communication (written and verbal)
• Effectively multi-task
• Able to work in an environment of change
• Able to work independently and as part of a team
• Acknowledge when problems are developing, not just occurring