Job Description
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
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 22.00/hr.