QC Analytical Scientist II: Method Transfer & Validation

ProKatchers LLC; Thousand Oaks (CA); On-site; USD 95,000 - 120,000; Full time

Job summary

ProKatchers LLC in Newbury Park, CA seeks a QC Analytical Scientist II to support method transfer, development and validation in a cGMP Quality Control environment.

The role focuses on analytical and microbiology methods, instrument qualification, investigations, and CAPA, with a requirement for a Bachelor's degree and at least 3 years of GMP pharma/biopharma experience. Strong knowledge of cGMP, USP, ICH and 21 CFR is essential.

Qualifications

• Bachelor’s degree in Chemistry, Biotechnology, Microbiology, Pharmacy, or related field with GMP pharmaceutical/biopharmaceutical experience.
• Experience performing IQ/OQ/PQ and analytical method validation.
• Strong knowledge of cGMP, USP, ICH, and 21 CFR regulations.

Responsibilities

• Support analytical method transfer, development, validation, and execution in a cGMP QC environment.
• Focus on analytical/microbiology methods, instrument qualification, troubleshooting, investigations, OOS/OOT, CAPA, and laboratory data analysis.
• Support new product testing, raw material qualification, analytical technologies, critical reagent qualification, and CMC paperwork.
• Ensure compliance with cGMP, USP, ICH, 21 CFR, and laboratory instrumentation standards.
• Apply statistical analysis and data interpretation to laboratory results.

Skills

IQ/OQ/PQ

validation

Education

Bachelor's degree in Chemistry, Biotechnology, Microbiology, Pharmacy, or related field

Job description

ProKatchers LLC in Newbury Park, CA seeks a QC Analytical Scientist II to support method transfer, development and validation in a cGMP Quality Control environment.

The role focuses on analytical and microbiology methods, instrument qualification, investigations, and CAPA, with a requirement for a Bachelor's degree and at least 3 years of GMP pharma/biopharma experience. Strong knowledge of cGMP, USP, ICH and 21 CFR is essential.