QA Specialist II

Our client a leading biotech company is looking for a skilled QA Specialist to join their team in San Diego County, CA!

Job Title:

QA Specialist Pay rate: $35/hr. - $52/hr.

DOE Job type:

Contract- hire

Location:

San Diego County, CA Overview The QA Specialist II is responsible for supporting day-to-day Quality Assurance operations within a GMP-regulated pharmaceutical manufacturing environment. This role ensures that drug substances manufactured meet FDA, EU, and other applicable regulatory requirements for research, pre-clinical, clinical, and commercial use. The position focuses on GMP documentation control, quality system oversight, and support of internal and external audits. Key Responsibilities Perform production room, dispensary, and shipment clearance verifications as required. Review, revise, and maintain Standard Operating Procedures (SOPs) and other GMP-controlled documents such as stability protocols, raw material specifications, and environmental monitoring trend reports. Manage GMP documentation workflows, including reconciliation, issuance, review, and archival of records. Verify accuracy of scanned batch production records (BPRs), chromatograms, and other GMP documents, ensuring proper labeling, boxing, and archiving. Coordinate, review, and approve quality events and associated documentation. Support internal, customer, and regulatory audits by providing required documentation and QA guidance. Provide cGMP guidance to manufacturing and cross-functional departments. Participate in continuous improvement initiatives and represent QA in cross-functional project teams. Implement and maintain Quality Management System (QMS) processes and standards. Scan, verify, and archive GMP records in compliance with internal procedures. Support system and process harmonization initiatives across sites and electronic quality systems (e.g., MasterControl). Qualifications Bachelor's degree in a science-related field required; Master's or Ph.D. preferred. 3-5 years of experience in Quality Assurance, Quality Control, or GMP manufacturing environment required. Experience working in ISO 7 and ISO 8 controlled environments preferred. Knowledge of FDA regulations, cGMP, GxP, and Quality Management Systems required. Experience with internal audits and regulatory inspections required. Strong ability to review GMP documents (including BPRs and chromatograms) with high accuracy. Proficiency in Microsoft Office (Word, Excel, PowerPoint) and electronic document management systems. Strong organizational, multitasking, and time-management skills in a fast-paced environment. Ability to work independently and collaboratively in cross-functional teams. Problem-solving ability and attention to detail essential.

Preferred certifications:

ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Process Analyst (CQPA). INDBH #LI-AH1