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

Quality Specialist II - OOS Deviation & Compliance

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:

Candidates should meet one of the following educational and experience requirements:

• 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.