QC Associate – Environmental Monitoring

Job Description

Job Summary:

• We are looking for a highly motivated and energetic candidate to join our growing business in the CMO industry.
• The QC Associate I will perform microbiological testing, static and dynamic viable and non-viable monitoring of classified clean room areas to support planned or in process manufacturing processes.

Responsibilities and Duties:

• Performs viable and non-viable environmental monitoring in a static and dynamic environment.
• Perform water quality analysis testing such as TOC and conductivity testing.
• Demonstrate excellent aseptic technique and clean room gowning practices required for working in Grade C, B and A spaces.
• Perform bioburden testing per current cGMP guidelines to facilitate in process product development and raw material release.
• Perform growth promotion, microbial identification, pure colony streak plate isolation, biological indicator testing in a controlled BSL2 environment.
• Complete relevant data entry requirements in accordance with current data integrity expectations and the ALCOA principals.
• Assist in laboratory investigations, environmental monitoring excursions and deviations.
• Participate and facilitate on-going lab excellence initiatives as directed by the Senior QC Associate or area management.
• Work may be required outside of normal business hours.
• Additional duties as needed.

Education and Experience:

• B.S in Biology or related field.
• 1-2 years working in a GMP facility is preferred, although not required.

Skills & Abilities:

• Excellent verbal and written communication skills.
• Ability to work independently or within a team setting.
• Team-player.
• Good organizational skills.
• General computer skills including Microsoft Office software.

Physical Demands:

• Able to lift up to 40 pounds.
• Able to work in a clean room suite while wearing appropriate gowning.
• General lab skills or science background desired.