More jobs:
Quality Assurance Specialist II
Job in
Oceanside, San Diego County, California, 92058, USA
Listed on 2026-09-22
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-09-22
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
- Quality Assurance Specialist II will provide hands-on support for production and quality operations, including batch record review, deviation management, and on-the-floor quality oversight.
- This role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP requirements within a biopharmaceutical manufacturing environment.
- The position supports quality systems, production activities, inspections, audits, documentation, and continuous compliance initiatives.
- Perform Quality Assurance activities including batch record review, line clearance, and on-the-floor production support.
- Provide QA oversight and approval of Quality Control activities, including method transfers, Certificates of Analysis (CoA), and stability data.
- Support and approve product shipments and packaging operations.
- Ensure timely review and closure of deviations, discrepancies, CAPAs, change controls, and laboratory investigations.
- Manage and resolve batch and material hold events in a timely manner.
- Communicate lot disposition status and pending issues to management.
- Conduct walkthroughs and process observations to ensure compliance with GMP standards.
- Provide real-time QA oversight to ensure manufacturing operations adhere to regulatory and quality requirements.
- Perform document control activities, including record archival and training documentation updates.
- Support regulatory inspections and audits, including preparation and execution support.
- Identify compliance risks and elevate issues as needed.
- Author and update SOPs, procedures, and forms.
- Perform additional duties as required to support quality and operational goals.
- Quality Assurance Specialist II will provide hands-on support for production and quality operations, including batch record review, deviation management, and on-the-floor quality oversight.
- This role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP requirements within a biopharmaceutical manufacturing environment.
- The position supports quality systems, production activities, inspections, audits, documentation, and continuous compliance initiatives.
- Perform Quality Assurance activities including batch record review, line clearance, and on-the-floor production support.
- Provide QA oversight and approval of Quality Control activities, including method transfers, Certificates of Analysis (CoA), and stability data.
- Support and approve product shipments and packaging operations.
- Ensure timely review and closure of deviations, discrepancies, CAPAs, change controls, and laboratory investigations.
- Manage and resolve batch and material hold events in a timely manner.
- Communicate lot disposition status and pending issues to management.
- Conduct walkthroughs and process observations to ensure compliance with GMP standards.
- Provide real-time QA oversight to ensure manufacturing operations adhere to regulatory and quality requirements.
- Perform document control activities, including record archival and training documentation updates.
- Support regulatory inspections and audits, including preparation and execution support.
- Identify compliance risks and elevate issues as needed.
- Author and update SOPs, procedures, and forms.
- Perform additional duties as required to support quality and operational goals.
- Quality Assurance Specialist II will provide hands-on support for production and quality operations, including batch record review, deviation management, and on-the-floor quality oversight.
- This role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP requirements within a biopharmaceutical manufacturing environment.
- The position supports quality systems, production activities, inspections, audits, documentation, and continuous compliance initiatives.
- Perform Quality Assurance activities including batch record review, line clearance, and on-the-floor production support.
- Provide QA oversight and approval of Quality Control activities, including method transfers, Certificates of Analysis (CoA), and stability data.
- Support and approve product shipments and packaging operations.
- Ensure timely review and closure of deviations, discrepancies, CAPAs, change controls, and laboratory investigations.
- Manage and resolve batch and material hold events in a timely manner.
- Communicate lot disposition status and pending issues to management.
- Conduct walkthroughs and process observations to ensure compliance with GMP standards.
- Provide real-time QA oversight to…
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