Please note that this is a 12-months contract position, onsite in Raritan, NJ.
Please note that there may be up to 10% domestic and/or international travel.
Qualifications
Education
Minimum, High School Diploma required
Minimum of 3 years of overall experience in a quality environment required
Knowledge, Skills, and Abilities
Travel Requirement
Summary
Supports product manufacture, validation, product-related projects, and investigations. Ensures quality systems activities and site projects are executed in compliance with company policies and procedures and applicable regulations and standards (e.g., QSR, CMDR and other international regulations per product, ISO 13485 standard, 21 CFR 200s).
Responsible for communicating and elevating critical business-related issues, as well as opportunities, to management.
Major Duties & Responsibilities
40% - Manage Distribution of Product Certificates of Analysis (CofA)
- Preparation of CofAs
- Assembly of appropriate documents
- Distribution to affiliates in a timely manner
- Submission of CofAs via the appropriate application
25% - Coordinate Printing and Receipt of Department Records
- Logging into the database
- Stamping records
- Creating lot files
- Filing appropriately (into correct product files)
- Reviewing batch records
- Retrieval of records for FDA or other audits
10% - Batch Record Error Tracking
- Input batch record errors into the Lot Tracking spreadsheet daily
10% - Controlled Documentation Maintenance
- Maintain all controlled documentation policies and procedures that apply to the department
- Process changes as required
15% - Records Archiving
- Archive department records according to current company policies
Candidates must provide their phone number. Job reference number is A5169.
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