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QA Specialist II/III (Production)

Astrix Technology Group -
Vista, CA

Quick Apply

Job Details

Contract
$40 - $55 an hour
2 days ago

Qualifications

Microsoft Excel
Investigations regulatory compliance
Laboratory document review
Document control experience within pharmaceutical industry
Calibration
Pharmaceutical regulatory compliance
Production deviation management
Corrective and preventive actions (CAPA)
Internal investigations
Manufacturing facility experience
Quality control data analysis
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Compliance documentation
Quality control experience within pharmaceutical industry
Productivity software
Production batch record review
Associate's degree
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Quality Assurance Specialist II/III (Production)

Location: Vista, CA
Job Type: 1-Year Contract (Potential for Conversion)
Pay Rate:

QA Specialist II: $40–45/hour
QA Specialist III: $45–55/hour

Shift: Sunday through every other Wednesday (rotating Sunday–Tuesday), 5:00 AM – 3:30 PM

Position Summary

Our client, a global pharmaceutical API manufacturer, is seeking a Quality Assurance Specialist II or III to support GMP manufacturing operations in a fast-paced production environment. This role is heavily focused on real-time quality support on the manufacturing floor, partnering closely with production teams to ensure products are manufactured in compliance with FDA and international regulatory requirements.

Approximately 80% of the role is spent on the production floor, providing QA oversight, reviewing documentation in real time, approving line clearances, and ensuring GMP compliance throughout the manufacturing process. This is an excellent opportunity for quality professionals who enjoy working directly with operations and making an immediate impact on manufacturing quality.

Responsibilities

Provide day-to-day Quality Assurance support for GMP manufacturing operations.
Spend approximately 80% of the workday on the production floor supporting manufacturing personnel.
Review batch production records (BPRs) in real time to ensure accuracy and GMP compliance.
Approve line clearances and support manufacturing activities during production.
Review and approve GMP documentation including batch records, validation protocols, reports, specifications, and supporting documentation.
Support electronic batch release systems and perform usage decisions.
Investigate and support deviations, CAPAs, OOS investigations, and other quality events.
Review QC data, including chromatograms and laboratory documentation.
Participate in document control, change controls, validation, qualification, and calibration activities.
Analyze and trend quality data to identify opportunities for continuous improvement.
Recommend and implement improvements to quality systems and SOPs utilizing Lean GMP principles.
Collaborate with Manufacturing, QC, and cross-functional teams to resolve quality issues and close quality records.
Provide GMP guidance and training to manufacturing and support departments.
Participate in internal, customer, and regulatory audits and support FDA inspections.
Assist with writing and revising SOPs, specifications, protocols, and other quality documents.
Promote a strong quality culture throughout the organization.

Qualifications

Education

Bachelor's degree in Chemistry, Organic Chemistry, Biology, or another related scientific discipline required.
Master's degree preferred.
Associate's degree will be considered with additional relevant experience.
High school diploma alone will not be considered.

Experience

QA Specialist II

3–5 years of Quality Assurance and/or Quality Control experience within pharmaceutical, biotech, or biologics manufacturing.
Associate's degree candidates should possess at least 5 years of relevant experience.

QA Specialist III

4–6 years of Quality Assurance and/or Quality Control experience within pharmaceutical, biotech, or biologics manufacturing.
Associate's degree candidates should possess at least 7 years of relevant experience.

Required Qualifications

Experience supporting GMP manufacturing or production floor operations.
Experience performing batch record review.
Experience reviewing QC data and chromatograms.
Experience with deviations, CAPAs, and OOS investigations.
Experience with GMP document control.
Knowledge of validation, qualification, and calibration activities.
Experience working in ISO 7 and/or ISO 8 controlled manufacturing environments.
Strong understanding of FDA and GMP regulations.
Excellent attention to detail and ability to work in a fast-paced manufacturing environment.
Strong communication and collaboration skills.
Proficiency with Microsoft Word, Excel, and PowerPoint.

Preferred Qualifications

Experience with peptides, oligonucleotides (oligos), APIs, biologics, or pharmaceutical products.
Experience with GxP regulations.
Experience participating in FDA, customer, or internal audits.
Experience with Quality Management Systems such as MasterControl or Veeva.
ASQ certifications such as:
- Certified Quality Auditor (CQA)
- Certified Quality Engineer (CQE)
- Certified Quality Process Analyst (CQPA)

Training

Comprehensive 90-day onboarding and training program.

Interview Process

Two interview rounds:
- Virtual interview with the Hiring Manager
- Onsite interview with the QA team

INDBH

Quick Apply

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QA Specialist II/III (Production)