Job Details

Duties:

• Primary responsibility is to execute routine Microbiology/Environmental monitoring, Raw Materials testing of bulk drug substance and drug product in a multi-product facility.
• Executes Raw Material sampling, Microbiological compendial testing and sampling of clean rooms (as applicable).
• Proficiency in 1-3 analytical methodologies.
• Performs technical and quality review of data.
• Responsible for routine lab maintenance work and quality and compliance activities.
• Performs duties under supervision and according to standard operating and QC procedures.
• Ensures that all data is organized and archived per appropriate workflows and SOPs.
• Works with GMP and non-GMP databases to ensure all samples are received, logged, stored, distributed and tracked within defined timelines.
• Interacts with Sample Management, QC laboratories and Raw Materials groups to prioritize samples, cross checks SOPs and protocols to ensure all samples have been received and distributed, troubleshoots discrepancies, and relays information back to line management to ensure all samples are tested per appropriate testing schedule.
• Coordinates shipment of samples to contract labs and other testing site.
• Maintain sampling and testing paper records, equipment logs and other controlled documentation.
• Ensure accuracy and completeness of sampling and testing in LIMS system and/or test records.
• Maintain cleanliness and orderliness of the labs.
• Perform QC-related data entry.
• Provides assistance to other group members as needed.
• Responsible for transferring samples from cleanrooms to the labs.
• Familiar with clean room gowning.

Skills:

• 1-3 years of GMP lab and/or clean room experience.
• Gowning and Aseptic techniques.
• Pipetting skills.
• Must be willing to work all shifts including weekend support if needed but primary work hours are during five days a week.

Education:

• Bachelor's Degree in a Scientific Discipline, preferably in Microbiology