Job Description
Job details
Proofreader Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a
Proofreader for a long-term engagement at one of our Global medical device & biotechnology clients in
Raritan NJ. Location: Raritan, NJ > can be hybrid, up to 2 days/week remote Schedule: Onsite, Monday through Friday, 9AM-5PM
Compensation: $30/hr Summary: The Proofreading - Data Integrity Analyst is responsible for ensuring high-quality documentation and compliance within the label design and development process to verify that all labeling meets regulatory and design requirements. The role includes accountability for the quality review of labeling for New Product Development, Lifecycle Management, and Process Improvement projects for Worldwide Product Labeling (WWPL) within a franchise of Global Surgery.
Responsibilities: - Following established procedures to perform quality reviews and edits of product labeling and packaging graphics.
- Documenting the quality review results as per Good Documentation Practices and providing constructive feedback for iterative design improvements by graphic designers.
- Conducting thorough reviews for compliance with content, format, grammar, punctuation, electronic navigation (hyperlinking), spelling, symbology, and regulatory standards.
- Approving final documentation, blue-lines, or color proofs supplied by vendors as necessary.
- Verifying design templates to ensure consistency in standardized label/IFU work.
- Utilizing quality control technologies, including collaborations with vendors to integrate tech effectively into the labeling process.
- Participating in or leading technology evaluations and process improvements to enhance documentation quality assurance.
- Maintaining records and documentation in accordance with regulatory requirements and quality systems.
- Tracking and reporting quality metrics.
- Keeping training and procedure knowledge up to date for all supported businesses within the quality framework.
- Supporting quality escalations and Corrective and Preventive Actions (CAPAs) as necessary.
- Assisting with change documentation as appropriate.
- POLICIES: Know & follow policies & procedures related to work activities performed in area of responsibility
- TRAINING: Complete training in area of responsibility within allowed time-period.
- Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.
- Complete required periodic re-training in areas such as safety & environmental
- SAFETY: Follow all company safety policies & other safety precautions within work area.
- Promote safety to all associates that enter work area Labeling
- Partner with designers and key stakeholders to execute labeling and IFU projects.
- Provide writing, proof-reading, and project management skills to ensure labeling and IFU projects are executed with accuracy.
- Follow proofing procedures/guidelines and document as per Good Documentation Practices
- Manage multiple projects.
- Regularly update stakeholders on project status
- Support process improvement initiatives within the department and company
- Collaborate across all Labeling Center of Excellence companies to ensure consistency in labeling execution.
- Provide documentation support for WWPL. Documentation may include spreadsheets, presentations, and project specific forms.
- Investigates and communicates internal and external customer inquiries and complaints.
- Use company-specific documentation systems to manage the storage and
Qualifications: Required- - GED/HSD
- 3+ years of related experience (Quality role preferred)
- Strong skills in quality review and documentation analysis
- Strong written and oral communication skills
- Interdependent Partnering
- Ability to effectively interact and partner
- Ability to conduct meetings, conferences and presentations.
- Mastering Complexity
- Ability to manage multiple projects competing for resources.
- Strong Analytical and Problem-Solving skills.
- Technical writing, editing and proofing
- Basic proofreading skills and knowledge.
- Ability to work with a high degree of concentration for several hours at a time.
- Fundamental knowledge of the English language; grammar and spelling.
- Organized and detail oriented.
- Influence and conflict resolution
- Ability to use personal computer and associated software
Preferred- - Bachelor's (BS/BA) focused on principles of quality control, quality management systems, and industry regulations.
- Experience in life sciences
- Experience in regulated industry - medical device
- Project management skills
- Domestic and international regulatory and legal regulations
- Knowledge of quality management systems and documentation standards
- Fluency in other languages in addition to English
What happens next Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover
what's next in your career is what we're all about,
#P1
Send resumes to
[email protected] 9848479 Kelly Services
Job Tags
Worldwide, 2 days per week, Monday to Friday,