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Supervisor, Quality Assurance - 2nd Shift

Company: Amneal Pharmaceuticals
Location: Piscataway
Posted on: November 22, 2021

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 requistions/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 - ExternalEducation:
                            • Bachelors Degree (BA/BS): Preferred degree in Chemistry, Biology or other related technical field - RequiredExperience:
                              • 3 years or more experience in Supervisory experience in FDA regulated industry, QA Manufacturing is preferred.
                                • 3 years or more with prior relevant work experience as a QA Inspector or QA Auditor is required.Skills:
                                  • To be a team leader and player who can successfully meet the organization's goals within a stipulated time frame. - Intermediate
                                    • Must be able to multitask and adapt to a rapidly changing environment. - Intermediate
                                      • Strong communication and writing skills. - Intermediate
                                        • Must be able to problem solve and make decisions with limited supervision. - Intermediate
                                          • Must be able to lead, coach and supervise the team with flexibility. - Intermediate
                                            • Microsoft Office; able to learn in-house computer systems and software. - IntermediateSpecialized Knowledge:
                                              • Knowledge of cGMPs.

Keywords: Amneal Pharmaceuticals, Trenton , Supervisor, Quality Assurance - 2nd Shift, Hospitality & Tourism , Piscataway, New Jersey

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