JOB TITLE: Sr. Document Control Specialist
Hours: 8am – 5pm
Hourly Pay Range: $26 - $33
Our Client is rapidly growing and looking to hire an experienced Sr. Document Control Specialist to join their team. This is a temp-to-hire opportunity offering opportunities for career advancement as the company begins to grow as well as a competitive benefits package.
This position is responsible for the label and document approval and distribution, procedural compliance, and site good documentation practices to ensure timely releases and distribution of documentation that supports delivering high quality and compliant products that meet and exceed our customer expectations. Must follow and comply with regulatory requirements as applicable to various processes, i.e. 21 CFR 820 & ISO 13485.
- Assist engineering, quality, purchasing and manufacturing personnel in the creation and processing of quality system documentation necessary to define product configurations, control manufacturing processes, and engineering changes.
- Coordinate the review and revision of procedures, specifications, parts lists, ECOs, BOM and forms; maintain the comprehensive filing system for all documents to be retained in the document control center.
- Process document change requests, provide timely distribution of documentation to all appropriate users, ensure that obsolete documentation is removed from distribution, and database updated.
- Review change control package against governing procedures to ensure it meets all applicable regulatory and internal requirements.
- Interact with the required departments to route change control documentation to ensure adequate approval.
- Support and administers the creation and approval of labeling, artwork and generation of specifications for label/insert sheet components of finished product, and maintains the controls for label copy portion of the Device Master Record.
- Prepare labeling packages for approvals. Responsible for clearly communicating and working with representatives of the Marketing and Regulatory Depts. to obtain the words and phrases and preliminary label design layout for product labeling. Coordinate translations as required.
- Conduct periodic training in relation to GDP/GMP or other change order / documentation related topics.
To Apply: Email your resume to email@example.com for consideration or call us at 949-757-4600!About Kimco:Kimco Staffing Services is a rapidly growing, award-winning staffing firm whose purpose is to add real value to our clients and candidates while"Changing lives, One Job at a Time."We have won Best Of Staffing Client and Talent satisfaction awards from Clearly Rated for the last 10 years. Only 2% of staffing companies nationwide receive this recognition! We support our teams, candidates, and clients with strong operational excellence and state-of-the-art industry software platforms.
- 4 years medical device industry experience (quality system document control experience preferred).
- Knowledge of the labeling and logo standards and of FDA and International Device labeling Regulations.
- Working knowledge and experience with EU, FDA, and Health Canada regulations and guidelines.
- Proficient in Microsoft Word and Excel.
- Strong written and verbal communication skills.
- Great attention to detail, problem solving and critical thinking skills.
- Ability to manage competing priorities in a fast-paced environment.