QA Supervisor: cGMP Compliance & Team Leadership

Regulatory Jobs; Piscataway Township (NJ); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Bonus potential

Job summary

Amneal is seeking a Supervisor, Quality Assurance to schedule and coordinate daily QA priorities for raw materials, in-process testing, and packaging operations. You will train and supervise QA inspectors and auditors to ensure SOP and cGMP compliance, while supporting CAPA activities and investigations.

You will monitor all stages of QA in-process/packaging operations and assist with SOP development and validation studies.

Qualifications

• Bachelor’s Degree (BA/BS): Minimum 1 year of pharmaceutical/manufacturing experience, including 1+ year in a supervisory or lead role
• Associate Degree (AA/AS): Minimum 5 years of pharmaceutical/manufacturing experience, including 2+ years in a supervisory or lead role
• High School Diploma or GED: Minimum 3 years of pharmaceutical/manufacturing experience, including 5+ years in a supervisory or lead role

Responsibilities

• Schedules and coordinates daily priorities for incoming raw materials, in-process materials, finished products and related sampling/inspection activities.
• Trains, supervises and evaluates QA inspectors, QA specialists and QA auditors to ensure SOP/cGMP compliance.
• Monitors all stages of QA in-process/packaging operations to ensure strict SOP/cGMP compliance.
• Assists management with SOP development, validates/qualifies studies, and runs investigations as needed.
• Handles CAPA, deviations, corrective actions and preventative actions using quality tools.
• Manages customer complaints: sampling, testing, report preparation and timely submission.
• Ensures batch records are audited per manufacturing/packaging/shipping requirements; conducts internal audits for SOP/cGMP compliance.

Skills

Supervisory experience

Quality Assurance

cGMP knowledge

Education

Bachelor’s Degree (BA/BS) with 1 year pharma experience

Associate Degree (AA/AS) with 5 years pharma experience

High School Diploma or GED with 3 years pharma experience

Job description

Amneal is seeking a Supervisor, Quality Assurance to schedule and coordinate daily QA priorities for raw materials, in-process testing, and packaging operations. You will train and supervise QA inspectors and auditors to ensure SOP and cGMP compliance, while supporting CAPA activities and investigations.

You will monitor all stages of QA in-process/packaging operations and assist with SOP development and validation studies.