Quality Specialist II — OOS Deviation & Compliance

Dawar Consulting, Inc.; El Segundo (CA); On-site; USD 58,000 - 63,000; Part time

Benefits offered by this job

Medical benefits

Paid sick leave

401K

Job summary

Dawar Consulting, Inc. is recruiting a Quality Specialist II focused on OOS deviations and compliance in El Segundo, CA.

The role supports QA operations in a fast-paced biologics environment, overseeing deviations, OOS investigations, CAPAs, change controls, and other quality events to ensure GMP regulatory compliance. The position involves collaboration with cross-functional teams, implementation of process improvements, and potential weekend or night work during campaigns, with a long-term

Qualifications

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

Responsibilities

• Provide QA oversight and approval for deviations, OOS investigations and CAPAs.
• Ensure quality records are initiated, investigated, documented and closed on time.
• Escalate deviations and quality issues per established procedures.
• Assist with resolution of in-process and finished product quality issues.
• Identify improvements to deviation and CAPA processes while maintaining compliance.
• Collaborate with Manufacturing, Quality Control, Engineering and other teams.
• Support QA activities during manufacturing campaigns, including possible weekend/night work.

Skills

QA oversight

OOS investigations

CAPA

Deviation management

Change control

GMP compliance

Cross-functional collaboration

Education

Master's degree in Biological Sciences or related field

Bachelor's degree + 2+ years relevant experience

Associate degree + 4+ years relevant experience

High School diploma + 5+ years relevant experience

Job description

Dawar Consulting, Inc. is recruiting a Quality Specialist II focused on OOS deviations and compliance in El Segundo, CA.

The role supports QA operations in a fast-paced biologics environment, overseeing deviations, OOS investigations, CAPAs, change controls, and other quality events to ensure GMP regulatory compliance. The position involves collaboration with cross-functional teams, implementation of process improvements, and potential weekend or night work during campaigns, with a long-term