Supervisor, Quality Assurance

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Supervisor, Quality Assurance to lead daily QA priorities for raw materials, labeling components, in-process testing, finished product sampling, and packaging operations. You will supervise QA inspectors, ensure cGMP/SOP compliance, and drive CAPA initiatives across all shifts.

The role requires a Bachelor’s or equivalent, with 1+ year supervisory experience in pharma manufacturing, strong knowledge of cGMP and SOPs, and a proven track record in QA leadership

Qualifications

• Bachelor’s degree with 1+ year pharmaceutical manufacturing supervision.
• Associate degree with 2+ years supervisory manufacturing experience.
• High school diploma with 5+ years pharmaceutical/manufacturing supervision.
• Knowledge of cGMPs and SOPs compliance.

Responsibilities

• Schedules and coordinates daily priorities for QA inspections, sampling, and packaging operations.
• Trains and evaluates QA inspectors, QA Specialists and QA Auditors for SOP and cGMP compliance.
• Monitors QA in-process and packaging operations to ensure cGMP/SOP compliance.
• Develops and revises SOPs; supports validation and qualification studies.
• Handles CAPA processes and corrective actions.
• Reviews and manages batch records, audits SOPs, and conducts internal audits for compliance.

Skills

Leadership

Supervisory experience

Quality Assurance understanding

Education

Bachelor’s Degree (BA/BS)

Associate Degree (AA/AS)

High School Diploma or GED

Job description

The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts.

Job Description

The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts.

Essential Functions

• Responsible for scheduling and coordinating daily priorities for incoming raw material, in-process material, finished product and in-process packaging/labeling operations sampling and inspection activities.
• Trains, supervises and evaluates the performance of QA inspectors, QA Specialist and QA Auditors to assure compliance with Standard Operating Procedures (SOPs)/cGMP.
• Responsible for final product: Monitors all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs.
• Assists management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required.
• Handles Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPA) through effective quality management tools.
• Handles customer complaints to include retrieval of samples, performing applicable tests, preparation of reports and submission before due date.
• Monitors and ensures that batch records are audited per manufacturing/packaging/shipping requirements, when required.
• Conducts internal audits for compliance with SOP, cGMP & FDA requirements.

Additional Responsibilities

• Initiates, investigates and completes CAPA for all QA unplanned deviations under the guidance of QA Manager.
• Writes, reviews and revises SOPs as directed by QA Manager/Director.
• Plans, monitors and supervises cross training of all QA Inspectors.
• Monitors absences and prepares Kronos, HR requestions/data change forms for all shift personnel, whenever required.
• Reviews performance of all QA Inspectors in the shift as and when directed by HR.

Qualifications

Education & Experience

• 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

Specialized Knowledge

• Knowledge of cGMPs.