Position Overview

We are seeking a Quality Assurance Specialist to review and process GMP documents, providing cGMP guidance across departments, supporting regulatory and customer audits, and managing quality documentation systems.

Location: Onsite in San Diego, CA
Hours: M-F 8-5
Type: Contract through the end of year (possibility for extension) 
Compensation Range: Level II : $34-$47/hour. Level III: $38-$58/hour (DOE) 

Key Responsibilities

Documentation & Compliance

• Review and approve all GMP documentation including batch production records (BPRs), validation protocols, analytical data, reports, specifications, and procedures.
• Verify scan accuracy of BPRs and chromatograms; ensure proper archiving with correct boxing and labeling.
• Revise standard operating procedures (SOPs) and other GMP documents such as stability protocols, raw material specifications, and environmental monitoring trend reports.
• Support real-time batch record review with high accuracy, performing usage decisions in electronic batch release systems.
• Collaborate with other functions to close out quality records and investigations (e.g., Out of Specification events).
• Conduct GMP audits for internal operations and compliance improvements.
• Provide GMP compliance guidance to other departments and sites.
• Train new hires and actively increase quality culture through guidance and training initiatives.

Required Qualifications

Education

• Bachelor's degree in science-related field with minimum 3-5 years in GMP/Manufacturing setting, OR
• Associate's degree in science-related field with minimum 5-7 years in GMP/Manufacturing setting.

Experience

• 3-6 years in Quality Assurance and/or Quality Control.
• 3-6 years working in ISO 7 and ISO 8 controlled environments supporting real-time batch record review.
• 3-6 years in internal auditing and working with regulatory agencies.
• Demonstrated ability to review scans of BPRs and chromatograms with high accuracy.

Knowledge & Skills

• Strong knowledge of cGMP, FDA regulations, and regulatory guidance.
• Understanding of Quality Management Systems and GxP requirements

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
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