Senior Analyst, Quality Control

Key Responsibilities

• Perform analytical/functional testing for raw material, in-process/bulk, finish goods, and stability products.
• Prepare internal QC reference template standards and assay samples/plates for QC testing.
• Review QC test records.
• Train and serve as Subject Matter Expert (SME) to lower-level analysts.
• Update/revise QC documents for improvement/compliance/efficiency.
• Monitor and trend testing data for improvements on specifications and processes.
• Provide technical input and lead investigation and nonconformance on QC testing failures and document resolution.
• Drive and create process change documentation to address testing and specification deficiencies as well as process improvement.
• Create/Execute QC Equipment SOP and Validations activities.
• Collaborate/Participate/Assist with R&D and Technical Transfer in test method transfer and drive method implementation in QC.

Qualifications

• A B.S. in molecular biology, biology, or related field with 5+ years of experiences in Quality Control or similar environment.
• Experience in molecular biology techniques.
• Innovative, highly process oriented, detail oriented, organized, and efficient.
• Strong team player and self-starter with the ability to work.
• Excellent verbal and written communication skills.
• Knowledgeable Quality Control process experiences in ISO 13485 and GMP environment.
• Statistical analysis experience a plus.

Pay

The base salary range for this full-time position is $90,000 - $100,000 + bonus + equity + benefits.