We seek a highly motivated and energetic Quality Control Senior Analyst to join a dynamic team of professionals in the Operations team to support the company mission. This position will be working in the Quality Control team to support all product testing activities from the start of raw material to the final finish good product as well as product stability. In addition, the position will include supporting new test method transfer, assay troubleshooting, deviations/nonconformance resolution, specification optimization, as well as streamlining existing test method procedures and documentation. Seeking a professional Sr. Analyst that is an astute learner with ability to adapt to shifting priorities in a fast-paced and rapid growing company, with strong understanding and adherence to established processes and procedures in compliance with ISO 13485/GMP requirements.

KEY RESPONSIBILITIES

• Perform analytical/functional testing for raw material, in-process/bulk, finish goods, and stability products.
• Perform data analysis and generate summary result documentation.
• Prepare internal QC reference template standards and assay samples/plates for QC testing.
• Review QC test records.
• Trainer and SME to lower-level analyst.
• 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 deficiency 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.

OCCASIONAL RESPONSIBILITIES

• Participate in test method validation activities
• May assist in other activities as needed

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.

The base salary range for this full-time position is $90,000 - $100,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.