Quality Assurance Engineer

PL Developments

6d•Onsite

About The Position

The Quality Assurance Engineer is responsible for supporting and maintaining quality systems within a regulated manufacturing environment, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and other applicable standards. This role involves analyzing production and laboratory data, investigating deviations, and driving corrective and preventive actions (CAPA) to resolve quality issues and prevent recurrence. The QA Engineer collaborates cross functionally with production, laboratory, and other departments to identify trends, improve processes, and ensure product quality and regulatory compliance.

Requirements

Associate degree with minimum of five (5) years of experience on similar job or bachelor’s degree on science or related fields from an accredited college or university with minimum of three (3) years of experience Preferred.
Experience working in a Pharmaceutical, Medical Devices or regulated industry.
Able to read and understand technical and regulatory literature.
Knowledgeable in cGMP’s and FDA regulations.
Planning and organization skills; and ability to manage multiple projects in parallel.
Attention to detail.
Previous experience leading/managing Quality Systems such as Investigation, CAPA, Change Control, etc.
Excellent interpersonal and communication skills.
High performance team and strong team player.
Computer proficiency: Word, Excel, and Power Point.
Able to work under pressure and meet deadlines.
Self-Starter able to work with minimal supervision.

Responsibilities

Receiving, filling, archiving and update data base for controlled documents, (BR’s logbooks, Reports, Protocols etc.).
Prepare/update and maintain other documents needed for the QA Department.
Issue to different department Controlled documents, (Form, logbooks, etc.)
Managing and tracking performance of Quality Systems (i.e., Change Control, CAPAs, Deviations/Investigation, Laboratory Investigations and Complaints) in Agile Enterprise Business system.
Run Oracle reports for completed training and approve all CRNs requested by system notification.
Updating document format prior to close the CRN.
Review and update assigned quality/operational procedures to assure compliance with Company Policies and Regulatory requirements.
Review and approves quality documents to assure correctness, completeness and compliance to company procedure and Regulatory requirements.
Prepare and maintain the Master Production Records
Create and send Issuance of notification for BR, WI, SOP and Validation Protocol.
Draft departmental NOE, minor deviations and investigations as required.
Perform all other tasks or projects assigned by the QA Manager or the Quality Director.