QA Specialist (Biotech / Pharmaceutical manufacturing)

dawarconsulting; Oceanside (CA); On-site; USD 55,000 - 69,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Paid Sick Leave

401K

Job summary

Our client, a world leader in biotechnology and life sciences, seeks a QA Specialist (Biotech / Pharmaceutical manufacturing) in Oceanside, CA to provide on‑the‑floor QA oversight, review batch records, and support QC activities while ensuring compliance with regulatory and site quality standards.

You will oversee deviations, CAPAs, change controls and investigations, assist regulatory inspections, and help maintain document control and procedures.

Qualifications

• QA oversight on the floor and batch record review experience.
• Strong GMP knowledge, US/EU compliance familiarity.
• MS Office proficiency; Veeva/Smartsheet/LIMS a plus.

Responsibilities

• Review batch records and perform line clearance to support QA on the floor.
• Provide QA oversight of QC activities including method transfer and COAs.
• Approve shipments and support packaging operations.
• Manage deviations, CAPAs, change controls, investigations and hold events.
• Support regulatory inspections and GMP compliance; assist document control.

Skills

QA oversight

Batch record review

Regulatory compliance

GMP knowledge

QA floor support

Tools

Veeva

Smartsheet

LIMS

Job description

Our client, a world leader in biotechnology and life sciences, is seeking a \"QA Specialist (Biotech / Pharmaceutical manufacturing). Location: Oceanside, CA Duration: Long-Term Contract (Possibility Of Further Extension) Pay Rate: $45/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K

Job Summary

This role provides on-the-floor QA oversight, batch record review, QC support, and ensures compliance with regulatory and site quality standards.

Key Responsibilities

• Review batch records, perform line clearance, and provide floor QA support
• QA oversight of QC activities (method transfer, COAs, stability)
• Approve shipments and support packaging operations
• Manage deviations, CAPAs, change controls, investigations, and hold events
• Support regulatory inspections and GMP compliance
• Perform walkthroughs, document control tasks, and update procedures/forms

Preferred Skills

• QC experience (analytical, virology, microbiology)
• Strong GMP knowledge (US/EU)
• MS Office; Veeva/Smartsheet/LIMS a plus