Quality Specialist II - OOS Deviation & Compliance

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

Job Description

Our client, a global leader in biotechnology, is seeking a highly motivated "Quality Specialist II" based at El Segundo, CA.

Duration: Long term contract (Possibility of further extension)

Pay Rate: $44/Hr on W2 + Medical Benefits, Paid Sick leave, 401K

We are seeking a highly motivated Quality Assurance Specialist II to support Quality Assurance Operations in a fast-paced biologics manufacturing environment. This role will provide QA oversight and approval for deviations, OOS investigations, CAPAs, change controls, and other quality events while ensuring compliance with applicable GMP and regulatory requirements.

Key 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.

Required Qualifications

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

Preferred Qualifications

• Experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
• Quality Control background in Analytical, Virological, or Microbiological testing.
• Experience with Deviation Management, OOS Investigations, CAPA, Change Control, and Quality Event investigations.
• Working knowledge of cGMP requirements and U.S. and EU regulatory standards.
• Strong investigation, problem-solving, documentation, and risk-assessment skills.

Skill Set

OOS, OOT, CAPA