QA Specialist II (Biotech/Pharma)

ASQ; Vista (CA); Presencial; USD 51.000 - 73.000; Jornada completa

Descripción de la vacante

ASQ is seeking an experienced Quality Assurance Specialist II to support GMP operations at a Vista, CA pharmaceutical/biotech manufacturing site. The role focuses on quality investigations, CAPA management, deviations, and OOS investigations to ensure FDA and international quality standards are met.

You will collaborate with Manufacturing, Quality Control, Engineering and other functions, lead cross-functional investigation teams, review reports, and drive CAPA effectiveness.

Formación

• Minimum 5 years QA experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Hands-on experience managing deviations, CAPAs, and OOS investigations.
• Demonstrated experience conducting root cause analysis and leading quality investigations.
• Experience supporting manufacturing operations in a GMP environment.
• Experience participating in or supporting internal quality audits.
• Strong understanding of FDA regulations and pharmaceutical quality systems.

Responsabilidades

• Serve as QA reviewer and approver for deviations, CAPAs, OOS investigations, and nonconforming materials.
• Lead complex quality investigations, performing RCA to identify underlying issues and corrective actions.
• Manage cross-functional investigation teams with Manufacturing, QC, Engineering and others.
• Review, author, and approve detailed investigation reports for accuracy and audit-readiness.
• Develop, implement, and monitor CAPA plans to address quality issues and mitigate risks.
• Support internal and customer/regulatory audits to ensure GMP compliance.
• Identify compliance risks and recommend corrective actions to maintain standards.
• Provide QA oversight to manufacturing operations and ensure adherence to procedures.
• Track quality metrics, timelines, and CAPA performance for management updates.

Conocimientos

Quality investigations

CAPA management

Root cause analysis

OOS investigations

FDA/cGMP knowledge

Cross-functional collaboration

Herramientas

Veeva

MasterControl

Descripción del empleo

Quality Assurance Specialist II – Pharmaceutical/Biotech Manufacturing

Location: Vista, CA

Job Type: Contract through June 2027

Pay Rate: $45/hour

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Start Date: ASAP

Work Arrangement: Onsite

Position Overview

We are seeking an experienced Quality Assurance Specialist to support GMP quality operations at a pharmaceutical/biotechnology manufacturing facility in Vista, CA.

This position will be responsible for managing quality investigations, deviations, Corrective and Preventive Actions (CAPAs), Out-of-Specification (OOS) investigations, and regulatory compliance activities to ensure pharmaceutical drug substances meet FDA and international quality standards.

The ideal candidate will have 5+ years of Quality Assurance experience within GMP-regulated pharmaceutical or biotechnology manufacturing, with a strong background in quality investigations, root cause analysis, CAPA management, and internal audits.

This individual will work closely with manufacturing, quality control, and cross-functional teams to resolve complex quality issues, identify potential risks, and drive continuous improvement initiatives.

Key Responsibilities

• Serve as the designated QA reviewer and approver for critical quality events, including deviations, CAPAs, OOS investigations, and nonconforming materials.
• Lead complex quality investigations, performing root cause analysis (RCA) to identify underlying issues and implement corrective actions.
• Manage and facilitate cross-functional investigation teams involving Manufacturing, Quality Control, Engineering, and other departments.
• Review, author, and approve detailed investigation reports, ensuring documentation is accurate, complete, and audit-ready.
• Develop, implement, and monitor CAPA plans to address quality issues, mitigate risks, and prevent recurrence.
• Evaluate CAPA effectiveness and recommend improvements to strengthen quality systems and manufacturing processes.
• Support internal audits, customer audits, and regulatory inspections to ensure compliance with applicable GMP requirements.
• Identify potential compliance risks and recommend corrective actions to maintain quality and regulatory standards.
• Provide QA oversight and support to manufacturing operations, ensuring adherence to approved procedures and quality requirements.
• Track quality metrics, investigation timelines, and CAPA performance, providing regular updates to management.
• Collaborate with cross-functional teams to support continuous improvement and strengthen site quality systems.
• Maintain accurate documentation within electronic Quality Management Systems (QMS).

Required Qualifications

• Minimum 5 years of Quality Assurance experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Strong hands-on experience managing deviations, CAPAs, and OOS investigations.
• Demonstrated experience conducting root cause analysis (RCA) and leading quality investigations.
• Experience supporting manufacturing operations in a GMP environment.
• Experience participating in or supporting internal quality audits.
• Strong understanding of FDA regulations, cGMP requirements, and pharmaceutical quality systems.
• Ability to independently investigate quality issues, identify risks, and implement corrective actions.
• Experience authoring, reviewing, and approving quality investigation reports and technical documentation.
• Strong organizational, analytical, problem-solving, and communication skills.
• Ability to collaborate effectively with Manufacturing, QC, Engineering, and other cross-functional departments.

Preferred Qualifications

• Previous experience in a QA Specialist III, Senior QA Specialist, QA Investigator, or similar role.
• Experience within Active Pharmaceutical Ingredient (API), peptide, oligonucleotide, or biologics manufacturing.
• Previous Quality Control laboratory experience combined with Quality Assurance experience.
• Experience with electronic Quality Management Systems such as Veeva, MasterControl, or similar platforms.
• Experience supporting FDA, EMA, MHRA, customer, supplier, or other regulatory audits.
• Familiarity with change controls, nonconformance management, and quality risk assessments.
• Experience developing and tracking quality metrics and CAPA effectiveness.
• Strong technical writing skills and experience preparing audit-ready documentation.

About the Opportunity

This opportunity is with an established global manufacturer specializing in the development and production of active pharmaceutical ingredients (APIs) for pharmaceutical and biotechnology applications.

The position offers the opportunity to support critical quality initiatives, collaborate with cross-functional manufacturing teams, and contribute to continuous improvement efforts within a growing GMP-regulated manufacturing environment.

Interview Process

First Interview: 30-minute virtual interview with the hiring manager.

Second Interview: Onsite panel interview with the team.

A hiring decision is anticipated following completion of the interview process.

Additional Information

• Contract assignment expected to continue through June 2027.
• Approximately 90-day training period.
• Full-time, onsite weekday schedule.
• Pre-employment background check and drug screening must be completed prior to starting.
• Candidates should have strong experience independently managing quality investigations and supporting GMP manufacturing operations.