Quality Assurance Specialist II: Deviation & CAPA Lead

DAWAR CONSULTING INC; El Segundo (CA); On-site; USD 123,984,000 - 130,872,000; Full time

Job summary

DAWAR CONSULTING INC in El Segundo, CA is seeking a Quality Specialist II to support QA operations in a fast-paced biologics manufacturing environment. The role provides QA oversight and approval for deviations, OOS investigations, CAPAs, change controls, and other quality events in compliance with GMP and regulatory standards.

You will collaborate with Manufacturing, QA, Engineering, and other cross-functional teams; assist with manufacturing campaigns, and ensure timely initiation,

Qualifications

• Master's degree in Biological Sciences or related field.
• Bachelor's degree with 2+ years of relevant experience.
• Associate degree with 4+ years of relevant experience.
• High School diploma with 5+ years of relevant experience.

Responsibilities

• Provide QA oversight and approval for deviations, OOS investigations, change controls, CAPAs, and event records of moderate to significant complexity.
• Ensure quality records are properly initiated, investigated, documented, and closed within established timelines.
• Ensure appropriate escalation of deviations and quality issues in accordance with established procedures.
• Support resolution of in-process product, final product, manufacturing, environmental, facility, equipment, and material-related quality issues.
• Identify opportunities to improve the efficiency and effectiveness of deviation and CAPA processes while maintaining compliance.
• Collaborate with Manufacturing, Quality Control, Engineering, and other cross-functional teams to resolve quality issues.
• Support QA activities during manufacturing campaigns, including occasional weekend or night work as needed.
• Maintain compliance with internal quality procedures and applicable U.S. and EU GMP regulations.

Skills

OOS investigations

CAPA

Deviation management

Change control

Quality records

Education

Master's degree in Biological Sciences

Bachelor's degree + 2+ years

Associate degree + 4+ years

High School diploma + 5+ years

Tools

GMP documentation systems

Quality event investigations software

Job description

DAWAR CONSULTING INC in El Segundo, CA is seeking a Quality Specialist II to support QA operations in a fast-paced biologics manufacturing environment. The role provides QA oversight and approval for deviations, OOS investigations, CAPAs, change controls, and other quality events in compliance with GMP and regulatory standards.

You will collaborate with Manufacturing, QA, Engineering, and other cross-functional teams; assist with manufacturing campaigns, and ensure timely initiation,