Quality Specialist II - OOS Deviation & Compliance

Uncover; El Segundo (CA); Hybrid; USD 51,000 - 70,000; Full time

Benefits offered by this job

Medical benefits

Paid sick leave

401K

Job summary

Our client in El Segundo, CA seeks a Quality Specialist II to support QA operations in a fast-paced biologics environment.

The role involves QA oversight for deviations, OOS investigations, CAPAs, change controls, and regulatory compliance with GMP standards. Collaboration with Manufacturing, QC, and Engineering is essential, with occasional weekend or night work as needed.

Qualifications

• Master's in Biological Sciences or related field, or Bachelor's with 2+ years QA experience.
• Bachelor's with 2+ years QA or Associate with 4+ years QA or HS with 5+ years QA are acceptable.
• Experience in GMP-regulated biopharma environments preferred.

Responsibilities

• Provide QA oversight and approval for deviations, OOS investigations, CAPAs, and event records of moderate to significant complexity.
• Ensure quality records are initiated, investigated, documented, and closed within established timelines.
• Escalate deviations and quality issues per procedures.
• Assist with in-process and finished product quality issues, environmental, facility, and equipment concerns.
• Improve deviation and CAPA processes while maintaining compliance.
• Collaborate with Manufacturing, QC, Engineering, and cross-functional teams to resolve issues.
• Support QA activities during manufacturing campaigns, including occasional off-hours.
• Maintain compliance with U.S. and EU GMP regulations.

Skills

QA oversight

Regulatory knowledge

Cross-functional collaboration

Documentation

Education

Master's in Biological Sciences

Bachelor's with 2+ years QA

Associate with 4+ years QA

High School with 5+ years QA

Tools

MS Word

Excel

PowerPoint

Job description

Our client, a global leader in biotechnology, is seeking a highly motivated "Quality Specialist II" to join its Antiviral Research team for 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.
• Perform additional quality-related responsibilities as assigned.

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.
• Ability to collaborate effectively and build strong relationships across cross-functional teams.
• Proficiency with Microsoft Word, Excel, PowerPoint, and other business applications.
• Excellent verbal and written communication skills.
• Ability to work effectively in a fast-paced environment and manage changing priorities.