Quality Control Analyst II/III

R&D Partners; Redwood City (CA); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

Medical insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Job summary

The Quality Control Analyst II/III will play a significant role in advancing and performing QC techniques, systems, policies, processes, and controls pertinent to the analytical examination of clinical materials. This is a 12-month contract position based in Redwood City, California.

Responsibilities include release testing for viral vector products under GxP guidelines, generating and interpreting analytical data for Drug Substance and finished products, and supporting SOP development and

Qualifications

• Bachelors in chemistry/biochemistry or related field with 3–5 years in QC II or III in HPLC bio-pharma lab.
• Proficient in HPLC systems and Empower software; hands-on with HPLC, PA800, MS.
• Experience with SEC, CE-SDS, DLS and similar analytical techniques.
• GxP knowledge and regulatory prerequisites for biotech/pharma.
• Familiarity with statistical methods for data analysis.
• Strong interpersonal, communication, and organizational skills.
• MS Office and Soft Max Pro proficiency.

Responsibilities

• Conduct release testing for viral vector products under GxP guidelines.
• Generate, analyze, and interpret analytical data for Drug Substance and finished products.
• Provide SME guidance on analytical methods, focusing on SEC.
• Develop, follow, and revise SOPs; participate in writing SOPs.
• Carry out release, stability, and in-process testing of materials and final products.
• Analyze results, identify deviations, propose corrective actions.
• Support method validation studies; draft protocols and reports.
• Assist in assay development and nonclinical testing for IND-path studies; lead QC projects.
• Mentor junior staff and liaise with contract testing labs.

Skills

HPLC operation

SEC

Mass spectrometry

DLS

CE-SDS

GxP knowledge

Statistical analysis

Interpersonal skills

MS Office

EMPOWER software

Education

Bachelor’s degree in chemistry/biochemistry or related field

Tools

Empower

SoftMax Pro

PA800

Job description

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
• 401k plan
• Employee Assistance Program
• Long‑term disability
• Weekly payroll
• 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.