GMP QA Leader: Compliance, CAPA & Process Improvement

JobSquad Staffing Solutions; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

JobSquad Staffing Solutions is seeking an experienced Quality Assurance Supervisor to provide leadership and oversight of quality systems within a regulated GMP manufacturing environment. This role ensures compliance, supports continuous improvement, and maintains high standards across manufacturing, packaging, laboratory, and quality operations.

The ideal candidate is a hands-on quality professional with strong knowledge of cGMP, investigations, validation, audits, CAPA, documentation, and

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field.
• 6+ years of Quality Assurance in a GMP manufacturing environment.
• Experience leading quality teams or mentoring staff.
• Strong knowledge of cGMP requirements and FDA regulations (21 CFR Parts 11, 111, 210, 211).
• Solid experience with quality systems, investigations, CAPA, change controls, validation, audits and regulatory compliance.
• Strong understanding of quality risk management and audit principles in a regulated manufacturing setting.
• Ability to read and apply SOPs, GMP requirements and governmental regulations.
• Excellent written and verbal communication with ability to convey quality requirements across levels.

Responsibilities

• Provide leadership and oversight of Quality Assurance programs including GMP compliance, labeling, document control, and quality metrics.
• Drive continuous improvement initiatives and quality performance metrics.
• Review and approve qualification, validation protocols, reports and related documentation.
• Utilize SPC and quality data to identify trends, risks, and improvement opportunities.
• Prepare and present KPI and quality trend reports to Senior Management.
• Review and approve manufacturing, packaging and quality operations processes and GMP documentation.
• Review and approve Master Labels and Certificates of Analysis for finished products.
• Develop, revise, and approve SOPs and controlled documents.
• Lead or support quality investigations including root-cause analysis and corrective actions.
• Support regulatory inspections and audits (FDA, DEA, customers).
• Assist in establishing raw material and finished product specifications.
• Support Annual Product Reviews and promote a strong quality culture across departments.

Skills

GMP compliance

Leadership

CAPA

FDA regs

Audit

Document control

QA metrics

Root cause analysis

Education

Bachelor’s degree in Chemistry/Biology/Pharma/Engineering

Job description

JobSquad Staffing Solutions is seeking an experienced Quality Assurance Supervisor to provide leadership and oversight of quality systems within a regulated GMP manufacturing environment. This role ensures compliance, supports continuous improvement, and maintains high standards across manufacturing, packaging, laboratory, and quality operations.

The ideal candidate is a hands-on quality professional with strong knowledge of cGMP, investigations, validation, audits, CAPA, documentation, and