Batch Record Review (Quality)

Overview

Praxis Packaging Solutions is an FDA-compliant packaging organization specializing in primary tablet filling of OTC & Rx packaging with industry-best serialization capabilities. 

We are seeking a motivated individual to join our team as a Work Order Compliance Specialist in the Quality Department. As a Work Order Compliance Specialist, you will be responsible to ensure that all production and control records are reviewed and approved by the quality control unit to ensure compliance with all established written procedures before a batch is released. Key attributes for success in this role will be working independently and strong attention to detail skills.

Employees at Praxis are from all over the world, and diversity in the workplace is respected and celebrated.  We offer two health insurance options, dental, vision, flex, and company paid short term disability, long term disability and life insurance.  We invest in our employees and provide a 4% 401k employer match.  Apply today if you are interested in joining a dynamic team in the pharma industry.

Responsibilities

Essential Functions and Responsibilities:

• Review final batch record documentation for completeness, accuracy, and compliance with regulatory and customer requirements
• Ensure timely correction of documentation errors, accurate material accountability, and customer yield compliance
• Identify and report discrepancies to appropriate departments for investigation
• Verify batch status in internal systems prior to release and ensure no QA holds are in place
• Complete Certificates of Compliance following batch record approval
• Communicate with customers regarding batch record questions and provide documentation via approved channels
• Monitor and ensure the accuracy of documentation related to incoming and finished product batches
• Enter and release finished goods in the Praxis system based on verified order quantities
• Confirm required customer samples are present and prepare documentation and packaging for shipment
• Support continuous improvement of the quality management system through quality objectives, audits, and corrective actions
• Performs any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.

Qualifications

Knowledge & Experience:

• • High school diploma or equivalent required.
  • 1 years similar experience required; 3 years, preferred.
  • The ability to work independently, without supervision required.
  • Ability to organize priorities and workload required.
  • Ability to work to work 8, 10, or 12-hour shifts as business needs require, including alternate shifts.

     Computer/Communication Skills:

• Working knowledge of MS Office programs: Word, Excel, and Outlook, preferred.
• Working knowledge of Enterprise Resource Planning (ERP) related software, preferred.
• Ability to speak, read and write English in a manner that is sufficient for effective communication with supervisors, employees, and customers: to include reading and writing skills to understand and complete necessary customer paperwork, required.

     Physical Requirements and Work Environment:

Normal office environment with little exposure to dust and weather conditions prevalent at the time (i.e., cold, hot/humid). Good (corrected) eyesight and hand/eye coordination. May also require visits to production area – where employee may be exposed to moving mechanical parts, dust and weather conditions prevalent at the time (cold, hot/humid). 

Pay Range