Quality Control Analytical Scientist II

Randstad USA; Thousand Oaks (CA); In loco; USD 69.000 - 85.000; Tempo pieno

Descrizione del lavoro

Randstad USA in Thousand Oaks, CA seeks a QC Analytical Scientist to drive analytical method development, instrument qualification, and QC support within a cutting-edge cGMP environment. You will solve complex analytical challenges and lead cross-functional site initiatives, enabling Right First Time execution.

The role requires a Bachelor's degree in a related field and at least 3 years of analytical development/validation experience in a biopharma setting, with strong GMP compliance and method

Competenze

• Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
• Minimum of 3 years of analytical development or validation experience in a cGMP pharmaceutical or biopharmaceutical manufacturing environment (or an advanced degree).
• Strong background in method transfer, troubleshooting, and cGMP compliance.

Mansioni

• Drive analytical method development, validation, and technology upgrades for laboratory methodologies and instrumentation.
• Lead the installation, operational qualification (IOQ), maintenance, and troubleshooting of AQC analytical instruments.
• Conduct and review laboratory investigations, providing scientific justification for iOOS, OOT, and atypical results.
• Author protocols, technical reports, and CMC submission documentation, including raw material qualifications.
• Support method transfers, execute assay control and critical reagent qualifications, and monitor method performance trends.
• Serve in project leadership roles across global and local site functions to ensure Right First Time (RFT) execution.

Conoscenze

SOP Development

GMP

Quality Control

Formazione

Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent

Descrizione del lavoro

Job Summary

Are you ready to elevate your career with a top-tier biopharmaceutical leader? We are seeking a QC Analytical Scientist to drive analytical method development, instrument qualification, and quality control support within a cutting-edge cGMP environment. If you excel at solving complex analytical challenges and leading cross-functional site initiatives, this is your next career move.

Job Summary

Are you ready to elevate your career with a top-tier biopharmaceutical leader? We are seeking a QC Analytical Scientist to drive analytical method development, instrument qualification, and quality control support within a cutting-edge cGMP environment. If you excel at solving complex analytical challenges and leading cross-functional site initiatives, this is your next career move.

location: Newbury Park, California

job type: Contract

salary: $50 - 62 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Drive analytical method development, validation, and technology upgrades for laboratory methodologies and instrumentation.
• Lead the installation, operational qualification (IOQ), maintenance, and troubleshooting of AQC analytical instruments.
• Conduct and review laboratory investigations, providing scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical results.
• Author protocols, technical reports, and CMC submission documentation, including raw material qualifications.
• Support method transfers, execute assay control and critical reagent qualifications, and monitor method performance trends.
• Serve in project leadership roles across global and local site functions to ensure Right First Time (RFT) execution.

Qualifications

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
• Minimum of 3 years of analytical development or validation experience in a cGMP pharmaceutical or biopharmaceutical manufacturing environment (or an advanced degree).
• Strong background in method transfer, troubleshooting, and cGMP compliance.

skills: SOP Development, Good Manufacturing Practices (GMP), Quality Control (QC)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.