Supervisor, Quality Assurance

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

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.

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.

The annual salary for this position ranges from $90,000 to $105,000 annually. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award , with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.