Senior QC Analytical Scientist: Method Development & Validation

Synectics Inc.; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. in Thousand Oaks, CA is seeking a QC Analytical Scientist II to support various QC activities within the AQC department, transferring and executing analytical methods for raw materials in a CGMP environment.

The role leads analytical method development and validation, equipment installation and qualification, investigations, and collaboration with cross-functional teams to ensure compliance and timely delivery.

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, chemistry or equivalent.
• Minimum of 3 years of analytical development or validation experience in GMP environments.
• Excellent technical writing skills for documents and regulatory reports.
• Strong knowledge of analytical methods and problem-solving.
• Knowledge of cGMP, USP, ICH and related regulatory standards.

Responsibilities

• Transfer and execute analytical methods for QC in CGMP environments.
• Lead analytical method development and validation of lab methodologies.
• Support investigations requiring analytical method input.
• Install, qualify, maintain and troubleshoot instrumentation in the AQC group.
• Review laboratory investigations, deviations, CAPAs, and periodic reviews.
• Deliverables to meet timelines and milestones.

Skills

Analytical development

Method validation

Technical writing

Data analysis

Statistical knowledge

Project management

Attention to detail

Multi-tasking

Education

Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent

Tools

Microsoft Office

Job description

Synectics Inc. in Thousand Oaks, CA is seeking a QC Analytical Scientist II to support various QC activities within the AQC department, transferring and executing analytical methods for raw materials in a CGMP environment.

The role leads analytical method development and validation, equipment installation and qualification, investigations, and collaboration with cross-functional teams to ensure compliance and timely delivery.