Supervisor, Quality Assurance - 2nd Shift
Company: Amneal Pharmaceuticals
Posted on: November 22, 2021
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
- 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
- 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
- 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
- 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
- Plans, monitors and supervises cross training of all QA
- 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:
Keywords: Amneal Pharmaceuticals, Trenton , Supervisor, Quality Assurance - 2nd Shift, Hospitality & Tourism , Piscataway, New Jersey
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