QC Analyst II/III - HPLC/SEC Specialist (12-Mo Contract)

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 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