Quality Control Analyst - Menlo Park, CA | Biospace
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Quality Control Analyst

IncellDx

Location:
Menlo Park, CA
Posted Date:
5/31/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

IncellDx is a growing molecular diagnostics company, dedicated to revolutionizing healthcare by combining molecular diagnostics with high throughput cellular analysis. We focus on critical life threatening diseases such as HPV/cervical cancer, HIV/AIDs, hepatitis, organ transplant infections, breast cancer and ovarian cancer.

Located in Menlo Park, CA, we have an opportunity for a full time Quality Control Analyst.
This is a lab/office position that encompasses quality control, manufacturing and inventory responsibilities. We are seeking a highly detail-oriented person.

Essential job requirements
•   Receive and inspect production materials, perform functional testing, and document conformance to specifications
•   Perform hands-on laboratory testing for quality control of product and materials
•   Perform a range of internal manufacturing procedures, including cell line expansion and isolation, filling, product labeling, packaging and assembly
•   Maintain manufacturing and QC equipment as necessary
•   Order and maintain QC reagents and supplies for internal testing
•   Trend quality control and product performance results
•   Design and perform stability studies to verify product shelf life; write study reports to summarize results
•   Conduct technical studies to support Quality Control, Manufacturing and Product Development; write technical protocols and reports
•   Write, revise and review Quality Control and Manufacturing documents
•   Investigate and document Non Conformance Reports and Corrective and Preventive Actions reports as needed
•   Ensure proper receiving, labeling and location of materials according to company SOPs; perform monthly inventory of products for accounting
•   Assist with Design Transfer documentation for the Design History File of new products
•   Assist in offsite storage facility management
•   Act as a back-up for shipping related activities
•   Be periodically on-call outside of business hours to ensure 24/7 temperature monitoring for products.
•   Work cross functionally as needed to support all company and department objectives.

Requirements

•   BS in Biochemistry, Molecular Cell Biology or related field
•   Minimum of 2 year of Quality Control experience in a scientific industry
•   Minimum 1 year of cell culture experience
•   Experience working in a GMP environment; good understanding of FDA Quality System Regulation and/or ISO 13485
•   Proficient in using basic lab equipment (micro-pipettors, microcentrifuge, cell analyzer)
•   Effective computer skills, especially proficient in Excel and Word
•   Excellent written and verbal communication skills; the employee must be able to read, write, and communicate fluently in English
•   Excellent interpersonal and organizational skills
•   Highly detail-oriented, yet flexible. Comfortable in a quick-paced environment, able to shift priorities when needed. Ability to multitask
•   Effective problem solving, troubleshooting and analytical skills
•   Flow cytometry experience is a plus

Work conditions and physical requirements
•   The work is performed indoors, in a general office environment and in a biology laboratory
•   Some tasks require the ability to work for extended periods of time at the lab bench, performing complex, repetitive manual tasks and detailed visual observations
•   Some tasks require the ability to work for extended periods of time on a computer
•   Some tasks require the use of hazardous and/or toxic chemicals and potentially hazardous biological materials, including human samples (Biosafety Level 2)
•   Some tasks require the ability to lift up to 40lbs