QC Analyst II

6550 Dumbarton Cir
Fremont, CA 94555, USA

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

• Provide timely analyses to support manufacturing and stability. This includes routine analyses of raw materials, in process and release of commercial product or clinical supplies
• Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications
• Provide accurate, written documentation of all work, including detailed observations and conclusions.
• Under general guidance, participate in laboratory investigations
• Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working environment

• Well-organized, capable of multi-tasking, and able to collaborate with individuals in a matrix environment
• Extensive hands‑on experience performing relevant analytical techniques (HPLC, GC, FTIR). Experience with EMPOWER a plus
• Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on problem solving
• Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.
• Knowledge of validation requirements for QC methods and regulatory guidelines

• Bachelor’s Degree in science or related field
• 2-5 years relevant experience in a cGMP pharmaceutical QC environment, or at least 1 year with a Master’s degree

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

The base salary for this role starts at $41/hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.

Equal Opportunity Employer
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