Quality Assurance Specialist - GMP Biotech Validation Lead

Yowei Therapeutics; Milpitas (CA); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k with company match

PTO 10 days for new hires

Company holidays

Job summary

CSBio in Milpitas, CA seeks a Quality Assurance Specialist to support the Quality Management System across deviations, CAPAs, document control, and validations. You will review OOS events, SOPs, and validation docs while ensuring GMP compliance and cross-functional collaboration with operations and manufacturing.

The role emphasizes risk assessment, quality improvements, recall support, and maintaining documentation aligned with ICH and FDA regulations in a fast-paced biotech environment.

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or related field.
• 3+ years in Manufacturing or Quality Control in a pharmaceutical, medical device or drug manufacturing company.
• 2+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company.
• Strong GMP knowledge and in depth understanding of ICH and FDA regulations.
• Thorough understanding of problem-solving and quality improvement tools and techniques.
• Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment.

Responsibilities

• Support Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints.
• Provide direction, assess and remediate, as appropriate, current and previous validation documentation, including conducting gap assessments, risk assessments, and development of standards.
• Review/approve OOS, deviations, CAPAs, SOPs, and operation documents.
• Create and provide guidance on phase-appropriate processes and systems.
• Review Risk Assessments, Process Development Reports, and Protocols.
• Quality support of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner.

Skills

Problem Solving

Teamwork

Organizational Support

Motivation

Adaptability

Education

Bachelor's Degree in Engineering, Life Sciences, Chemistry, or related field

3+ years in Manufacturing or Quality Control in a pharmaceutical, medical device or drug manufacturing company

2+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company

Job description

CSBio in Milpitas, CA seeks a Quality Assurance Specialist to support the Quality Management System across deviations, CAPAs, document control, and validations. You will review OOS events, SOPs, and validation docs while ensuring GMP compliance and cross-functional collaboration with operations and manufacturing.

The role emphasizes risk assessment, quality improvements, recall support, and maintaining documentation aligned with ICH and FDA regulations in a fast-paced biotech environment.