• QA Specialist II/III

    Astrix Technology (San Diego, CA)


    QA Specialist II/III

     

    Quality Assurance

     

    San Diego, CA, US

    Pay Rate Low: 34 | Pay Rate High: 58

    + Added - 13/11/2025

     

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    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!_

    _\#INDBH_

    _\#LI-DNP_

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.