Job #: 15101
Title: Technical Document Reviewer (Pharma)
Job Location: Charlotte, North Carolina - United States
Salary: $35,000.00 - $55,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Negotiable
WHY IS THIS A GREAT OPPORTUNITY?
We are looking for Technical Document Reviewer with pharma experience. This position will be responsible for working within the Quality Systems organization supporting the review, development and implementation of harmonized documents, processes and systems. JOB DESCRIPTION
- Review of documentation from various suppliers and other sites for use at site.
- Creation of site-specific specifications, standard test procedures, general test procedures, test data sheets and any other documentation required.
- Preparation and review of Certificate of Analysis.
- Communicate with laboratory staff, research and development and any other stakeholders to proactively address the quality of documentation. Consults with supervisor regarding priority of assignments.
- Help establish systems for tracking progress and providing updates for key processes and projects.
- Manage documentation within QA to ensure compliance with internal procedures, USP and regulatory requirements.
- Support business unit and corporate harmonization initiatives as they pertain to the quality management system.
- Ensures all documents are traceable and easily retrievable.
- Ensures Quality Systems are compliant with SOPs.
- Participate in projects, investigations or audits that impact department.
- Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems.
- Ensure processes are performed per SOP.
- Write and revise SOPs and related documents to ensure best practices and current operations.
- Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
- Maintain quality system controls to ensure state of compliance and no critical and major market complaints.
- Take appropriate steps to reduce waste and losses in the process and build improved efficiency.
- Minimum bachelors degree in science or related discipline is required
- Minimum of 2 years previous experience in related field
- Intermediate-level professional contributor on a project or specialty work team
- Occasionally a masters degree can substitute for some or all of the required previous experience in related field
- Lab/analytical experience is highly preferred.
- Previous cGMP experience is required.
- Previous Pharmaceutical, FDA and/or Quality experience is preferred.
University - Bachelor`s Degree/3-4 Year Degree
How to Apply: