QC Associate I

Position Title: QC Associate I

Work Location: Fremont, CA 94555

Assignment Duration: 6+ Months

Work Arrangement: Onsite (1st Shift: Mon-Fri, 8:00AM-5:00PM)

Position Summary:

Primary responsibility is to execute routine Microbiology/Environmental monitoring, Raw Materials testing of bulk drug substance and drug product in a multi-product facility.

Key Responsibilities:

* 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.

Qualification & Experience:

* 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, preferrably in Microbiology