Quality Assurance Specialist II

Katalyst CRO; Oceanside (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

Katalyst CRO is seeking a Quality Assurance Specialist II to provide hands-on QA support for production and quality operations in a biopharmaceutical manufacturing environment. The role ensures product quality, regulatory compliance, and GMP adherence, supporting quality systems, production activities, inspections, audits, documentation, and continuous compliance initiatives.

Responsibilities include batch record review, on-the-floor production support, deviation management, CAPA, change

Qualifications

• Relevant experience in quality assurance, quality control, or GMP manufacturing.
• Experience with deviation management, CAPA, and change control processes.
• Familiarity with batch record review, product release, and QA oversight activities.
• Knowledge of GMP standards aligned with US/EU regulations.
• Experience with systems such as Veeva, Smartsheet, and LIMS.

Responsibilities

• Perform QA 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 escalate issues as needed.
• Author and update SOPs, procedures, and forms.
• Perform additional duties as required to support quality and operational goals.

Skills

Attention to detail

Communication skills

GMP knowledge

Regulatory compliance

Documentation

Education

Bachelor's degree in Biological Sciences or related field

Master's degree

Associate degree with 4+ years of experience

High school diploma with 5+ years of relevant experience in biological sciences

Tools

Veeva

Smartsheet

LIMS

Microsoft Office

Job description

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 escalate issues as needed.
• Author and update SOPs, procedures, and forms.
• Perform additional duties as required to support quality and operational goals.

Job Summary

• 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.

Roles & Responsibilities

• 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 escalate issues as needed.
• Author and update SOPs, procedures, and forms.
• Perform additional duties as required to support quality and operational goals.

Education & Experience

• Relevant experience in quality assurance, quality control, or GMP manufacturing environments.
• Experience supporting deviation management, CAPA, and change control processes.
• Familiarity with batch record review, product release, and QA oversight activities.
• Experience working in regulated biopharmaceutical or life sciences environments.
• Background in analytical, virological, or microbiological Quality Control testing.
• Working knowledge of GMP standards aligned with U.S. and EU regulations.
• Experience with systems such as Veeva, Smartsheet, and LIMS.
• Bachelor's degree with 2+ years of experience, OR Master's degree, OR Associate degree with 4+ years of experience, OR High school diploma with 5+ years of relevant experience in biological sciences or a related field required.
• Strong understanding of GMP compliance and quality systems.
• Excellent attention to detail with a focus on accuracy and completeness.
• Strong organizational and time management skills.
• Effective communication and interpersonal skills in a collaborative environment.
• Ability to identify risks and proactively escalate issues.
• Strong problem-solving skills with the ability to manage complex quality scenarios.Flexibility to support weekend and off-hours work during manufacturing campaigns.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).