Quality Control Analyst II/III

The Quality Control Analyst II/III will play a significant role in advancing and performing Quality Control (QC) techniques, systems, policies, processes, procedures, and controls pertinent to the analytical examination of clinical materials.

This is a 12-month contract position based in Redwood City, California.

Responsibilities

• Conduct release testing in alignment with nonclinical and clinical viral vector products, adhering to GxP guidelines.
• Generating, analyzing, and interpreting analytical testing data for Drug Substance and finished products, ensuring the accuracy and reliability of the results.
• Providing technical expertise as a subject matter expert in the implementation, execution, and troubleshooting of analytical methods within the testing laboratory, specifically focusing on SEC.
• Develop, understand, follow, optimize, modify, and/or assist in the development of standard operating procedures (SOPs); partake in writing, reviewing, and revising SOPs.
• Carry out release, stability, and in-process testing of materials, samples, and final products.
• Execute analysis and interpretation of test outcomes, pinpoint deviations, and propose suitable recommendations.
• Engage in method and equipment qualification/validation studies; generate protocols, carry out and coordinate experiments, and draft reports.
• Assist in assay development, nonclinical sample testing to support IND-path studies, and lead QC projects and investigations when necessary.
• Offer guidance to junior staff, apply technical knowledge daily, and may liaise with contract testing labs.

Qualifications

• Bachelor’s degree in chemistry, Biochemistry, or a related field, with a minimum of 3-5 years of experience (QC II) or 3-5 years’ experience (QC III) in HPLC, preferable in a bio-pharma analytical laboratory setting
• Proficient knowledge of calibration and operation of HPLC system with Empower software, along with hands-on experience in handling equipment like HPLC, PA800, Mass Spectrometry and others
• Laboratory experience with a range of analytical techniques including, but not limited to, SEC, CE-SDS, DLS and similar methods is required
• Experience in quality control is desired to required based on the level; a solid foundation in molecular biology is desired.
• Experience with viral vector (adeno-associated virus) products is a plus.
• Must possess knowledge of cGMPs and regulatory prerequisites concerning the biotechnology and pharmaceutical sectors.
• Familiarity with statistical methods applicable to the analysis of experimental data.
• Proficiency in general and non-routine laboratory skills.
• Exceptional interpersonal, communication, and organizational skills are a must.
• Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.

Pay

• $50-$60/hr

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.